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NCT Number: NCT07493395

Phase IIa Trial of Anti-CD19 CAR T-Cells in Systemic Sclerosis Resistant to Immunosuppressive Therapy

The goal of this clinical trial is to evaluate whether anti-CD19 CAR T-cell therapy can improve disease activity in adults with severe, treatment-resistant systemic sclerosis (SSc). The study will also assess the safety of this therapy and how CAR T-cells behave in the body.

The main questions are:

Does CAR T-cell therapy reduce skin thickening and other signs of SSc? What side effects occur after receiving CAR T-cells? How do CAR T-cells expand, persist, and affect B-cells and autoantibodies?

Participants will:

Undergo leukapheresis Receive short lymphodepleting chemotherapy Receive one infusion of anti-CD19 CAR T-cells Stay in the hospital for about 10 days Attend follow-up visits for 24 months with clinical exams, blood tests, and organ-function assessments

Optional skin or lymph-node biopsies may be performed in participants who consent to these procedures.

This study aims to provide early evidence on whether CAR T-cell therapy could become a promising treatment option for systemic sclerosis.

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Key information

Conditions

Scleroderma, Systemic Connective Tissue Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHRU Lille, Lille, France

Loading trial locations.

About this study

Systemic sclerosis (SSc) is a rare and severe autoimmune disease characterized by fibrosis of the skin and multiple organs, vasculopathy, and immune dysregulation. Many patients continue to experience active and progressive disease despite conventional immunosuppressive treatments, including disease modifying antirheumatic drugs (DMARDs) and biologics. Therapeutic options remain limited, and there is a significant unmet medical need for innovative approaches targeting the underlying mechanisms of the disease.

Recent preliminary experience from studies conducted in autoimmune diseases-such as lupus, myositis, and systemic sclerosis-suggests that autologous anti CD19 CAR T cell therapy may help reduce disease activity. Reported observations include transient B cell depletion, decreases in autoantibody levels, and improvements in joint, pulmonary, and cardiac manifestations. These early results support further evaluation of CAR T cell therapy in systemic sclerosis in a structured clinical trial setting.

This Phase IIa, multicenter, single-arm study is designed to evaluate the feasibility and safety of autologous anti-CD19 CAR-T cell therapy in adults with active systemic sclerosis who are resistant to immunosuppressive treatments. The study also aims to generate early clinical and biological data to assess the potential value of this therapeutic strategy in this population.

Eligible participants will undergo leukapheresis for T-cell collection. Following standard manufacturing of autologous anti-CD19 CAR-T cells in a GMP (Good Manufacturing Practice)-certified facility, participants will receive a short course of lymphodepleting chemotherapy, followed by a single intravenous infusion of CAR-T cells. They will remain hospitalized for intensive monitoring during the early post-infusion period, in accordance with established procedures for CAR-T cell therapies. Participants with known hypersensitivity to drugs required for treatment-related toxicity are excluded, as specified in the protocol.

After discharge from the hospital, participants will have follow-up visits for up to 24 months. These visits will include clinical and biological assessments as well as appropriate imaging tests to monitor disease activity, treatment safety, and overall health status. Biological samples will also be collected at specific times for centralized analysis.

The study incorporates exploratory immunological and translational research components. These may include monitoring circulating CAR T cells, characterizing immune cell subsets, and evaluating selected biomarkers. Optional skin and lymph node biopsies may be performed in consenting participants to analyze immune cell phenotypes and tissue level changes associated with treatment. Additional exploratory analyses may assess the spatial organization and distribution of immune cells within tissue samples, as described in the study protocol.

Overall, the study aims to provide early data on the use of anti CD19 CAR T cell therapy in systemic sclerosis, including feasibility, safety, and biological signals of activity. The results are expected to contribute to the development of innovative cell based therapeutic strategies for this severe autoimmune disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Pre-Inclusion criteria:

  • Diagnosis of systemic sclerosis according to ACR/EULAR 2013 classification (15).we include in the critera the fulfilling of 2013 EULAR/ACR criteria and specify disease duration (less than 2 years), score/clinical evidence for active disease :
  • Severe and resistant to low dose steroids and at least 2 immunosuppressive treatment including csDMARDs (methotrexate, azathioprine, mycophenolate mofetil) and at least one bDMARDs (Tocilizumab)
  • Early onset (less than 2 years).
  • Severity & progression of disease be defined by :
  • .mRSS >15 with at least one organ involvement (lung: FVC <80%, renal involvement, cardiac involvement, Creatinine < 1.5 mg/dl within 6 months).
  • mRSS <15 and lung fibrosis progression (FVC -10% DLCO -15% within 6 months)
  • patients with active disease (as defined by EUSTAR ≥2.5) and to patients with a worsening disease despite 6 months of at least 2 immunosuppressive treatments including one DMARDs (methotrexate, azathioprine, mycophenolate mofetil), and one biological DMARD rituximab or tocilizumab.
  • Estimated survival time > 24 weeks
  • Age: ≥18 ≤64 years old voluntary to participate in the study and sign the informed consent
  • Adequate organ functions assessed :
  • serum Creatinine clearance > 40ml/mi
  • adequate bone marrow function (Hemoglobin ≥9g/dL ; PMN ≥ 1 G/L ; Platelets ≥ 100 G/L)
  • Alanine aminotransferase (ALT) ≤ 3 x ULN and total bilirubin < 2.0 mg/dL (34 μmol/L) (or < 3.0 mg/dL [51 μmol/L] for subjects with Gilbert's syndrome)
  • Adequate respiratory function: no dyspnea or grade I dyspnea (Common Terminology Criteria for Adverse Events (NCI CTCAE v 5.0) and oxygen saturation >/= 92% on room air
  • Highly effective contraception methods

Inclusion criteria

  • Adequate organ functions assessed:
  • serum Creatinine clearance > 40ml/mi
  • adequate bone marrow function (Hemoglobin ≥9g/dL ; PMN ≥ 1 G/L ; Platelets ≥ 100 G/L)
  • Alanine aminotransferase (ALT) ≤ 3 x ULN and total bilirubin < 2.0 mg/dL (34 μmol/L) (or < 3.0 mg/dL [51 μmol/L] for subjects with Gilbert's syndrome)
  • Adequate respiratory function: no dyspnea or grade I dyspnea (Common Terminology Criteria for Adverse Events (NCI CTCAE v 5.0) and oxygen saturation >/= 92% on room air
  • Adequate venous access for apheresis
  • Leucapheresis : a wash-out period of 6 weeks for conventional immunosuppressants (i.e. methotrexate, mycophenolate mofetil)
  • Leucapheresis : at least 12 weeks after biotherapy (i.e. tocilizumab, 6 months for rituximab),

Exclusion criteria

  • Craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia or cerebrovascular hemorrhagic diseases
  • ECG showing prolonged QT interval or history of severe heart diseases or FEVG < 40%
  • Lung and / or heart severe dysfunction defined by CVF<50% and/or DLCO <40%
  • Pulmonary arterial hypertension defined by catheterism (mean AP > 25mmHg at rest or > 30mmHg after exercise, PAOP < 15mmHG)
  • Clinically significant active, opportunistic, chronic or recurrent infection (including but not limited to: hepatitis B or C virus or HIV) or covid-19 < 1 months including active or latent tuberculosis (TB) infection
  • Contra indication for autologous hematopoietic stem cell transplantation (AHSCT ) or relapsing at least one year after AHSCT
  • Active hematological or solid neoplasm
  • Concurrent therapy with systemic steroids (>10 mg/d prednisone equivalent) within 2 weeks prior to inclusion, except inhaled steroids
  • Methylprednisolone or prednisone (maximum dose 20 mg) instead of immunosuppressive agents
  • T cell targeting drugs (e.g. mycophenolate mofetil, azathioprine, calcineurin inhibitors) within 6 weeks prior to leukapheresis
  • Previous adoptive T cell therapy or any gene therapy including CAR T cell therapy
  • Live vaccines within 6 weeks prior to leukapheresis
  • Hypersensitivity against any drug or its ingredients/impurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory preparative chemotherapy or rescue medication/salvage therapies for treatment related toxicities
  • patients without social security coverage;
  • patients under guardianship;
  • Male or female patients seeking to conceive a child
  • Women of childbearing potential unless they are using a highly effective method of contraception starting from the time of enrolment and for at least 12 months following LD chemotherapy and until clearance of CAR-T cells, and sexually active male participants unwilling to use a condom. Female partners of sexually active male participants must be on a highly effective form of birth control from the time of enrolment and for at least 12 months following LD chemotherapy and until clearance of CAR-T cells.
  • pregnant or breastfeeding women;
  • patients with advanced cognitive disorders or any other cause preventing their informed consent;
  • active, clinically significant CNS pathology : If signs or symptoms exist which present diagnostic uncertainty, neurologist consultation will be obtained to confirm the diagnosis of any neurological condition
  • any comorbidity, whatever it may be, which may, in the opinion of the investigator, place the patient at additional risk or interfere with the monitoring of the study.
  • Concurrent participation in any other interventional trial and Contraindication to the lymphodepleting chemotherapy

Treatment and study plan

CD19 CAR T Arm

Biological

Autologous anti-CD19 CAR-T cells are generated from the participant's leukapheresis product in a Good Manufacturing Practice (GMP)-certified facility using a lentiviral vector.

Prior to infusion, participants will receive a short course of lymphodepleting chemotherapy.

A single intravenous infusion of autologous anti-CD19 CAR-T cells will be administered on Day 0 at a target dose of 1 × 10⁶ CAR-T cells/kg. Participants will then be monitored in the hospital in accordance with standard post-CAR-T cell infusion procedures.

Primary outcomes

  1. modified Rodnan skin score (mRSS)

    Time frame: 6 Months

    Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis)

Secondary outcomes

  1. Change in European Scleroderma Trial And Research (EUSTAR) activity index

    Time frame: From 3 months to 1 month before CAR-T cell infusion

    Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) >18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein >1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted <70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease

  2. Change in European Scleroderma Trial And Research (EUSTAR) activity index

    Time frame: 1 month before CAR-T cell infusion

    Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) >18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein >1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted <70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease

  3. Change in European Scleroderma Trial And Research (EUSTAR) activity index

    Time frame: Day 0 (CAR-T cell infusion)

    Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) >18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein >1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted <70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease

  4. Change in European Scleroderma Trial And Research (EUSTAR) activity index

    Time frame: Day 28 after CAR-T cell infusion

    Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) >18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein >1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted <70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease

  5. Change in European Scleroderma Trial And Research (EUSTAR) activity index

    Time frame: 3 Months

    Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) >18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein >1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted <70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease

  6. Change in European Scleroderma Trial And Research (EUSTAR) activity index

    Time frame: 6 Months

    Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) >18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein >1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted <70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease

  7. Change in European Scleroderma Trial And Research (EUSTAR) activity index

    Time frame: 12 Months

    Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) >18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein >1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted <70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease

  8. Change in European Scleroderma Trial And Research (EUSTAR) activity index

    Time frame: 24 Months

    Clinical response will also be assessed through the European Scleroderma Trial And Research (EUSTAR) disease activity (range 0-10, higher scores indicating greater disease activity) based on a weighted 10-point activity index : Δ-skin=1.5 (Δ=patient assessed worsening during the previous month), modified Rodnan skin score (mRss) >18=1.5, digital ulcers=1.5, tendon friction rubs=2.25, C-reactive protein >1 mg/dL=2.25 and diffusing capacity of the lung for CO (DLCO) % predicted <70%=1.0. A cut-off ≥2.5 was found to identify patients with active disease

  9. modified Rodnan skin score (mRSS)

    Time frame: From 3 months to 1 month before CAR-T infusion

    Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis)

  10. modified Rodnan skin score (mRSS)

    Time frame: 1 month before CAR-T infusion

    Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis)

  11. modified Rodnan skin score (mRSS)

    Time frame: Day 0 (CAR-T infusion)

    Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis)

  12. modified Rodnan skin score (mRSS)

    Time frame: Day 28 after infusion

    Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis)

  13. modified Rodnan skin score (mRSS)

    Time frame: 2 Months

    Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis)

  14. modified Rodnan skin score (mRSS)

    Time frame: 3 Months

    Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis)

  15. modified Rodnan skin score (mRSS)

    Time frame: 6 Months

    Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis)

  16. modified Rodnan skin score (mRSS)

    Time frame: 12 months

    Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis)

  17. modified Rodnan skin score (mRSS)

    Time frame: 24 months

    Clinical response will be assessed through the modified Rodnan skin score (mRSS) which measures skin thickness on a scale of 0 to 3 at 17 anatomical sites (score range 0-51, higher scores indicating worse skin fibrosis)

  18. Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS)

    Time frame: From 3 months to 1 month before CAR-T infusion

    Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).

    The rCRISS is a 2-step composite score:

    Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% <80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.

    Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.

    Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score

  19. Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS)

    Time frame: 1 month before CAR-T infusion

    Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).

    The rCRISS is a 2-step composite score:

    Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% <80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.

    Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.

    Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score

  20. Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS)

    Time frame: Day 0 (CAR-T infusion)

    Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).

    The rCRISS is a 2-step composite score:

    Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% <80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.

    Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.

    Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score

  21. Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS)

    Time frame: Day 28 after infusion

    Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).

    The rCRISS is a 2-step composite score:

    Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% <80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.

    Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.

    Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score

  22. Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS)

    Time frame: 2 Months

    Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).

    The rCRISS is a 2-step composite score:

    Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% <80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.

    Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.

    Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score

  23. Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS)

    Time frame: 3 Months

    Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).

    The rCRISS is a 2-step composite score:

    Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% <80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.

    Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.

    Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score

  24. Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS)

    Time frame: 6 Months

    Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).

    The rCRISS is a 2-step composite score:

    Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% <80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.

    Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.

    Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score

  25. Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS)

    Time frame: 12 Months

    Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).

    The rCRISS is a 2-step composite score:

    Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% <80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.

    Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.

    Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score

  26. Change in Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS)

    Time frame: 24 Months

    Clinical response will be assessed using the revised Combined Response Index in diffuse cutaneous Systemic Sclerosis (rCRISS).

    The rCRISS is a 2-step composite score:

    Step 1: Patients are considered not improved if any of the following occur: scleroderma renal crisis, significant FVC decline (≥15% or FVC% <80%), new left ventricular failure (LVEF ≤45%), new pulmonary arterial hypertension requiring treatment, gastrointestinal dysmotility requiring nutritional support, or digital ischemia requiring treatment or hospitalization.

    Step 2: For other patients, improvement is defined as ≥40% improvement in at least 3 of 5 measures: mRSS, HAQ-DI, patient global assessment, clinician global assessment, and percent predicted FVC.

    Additional assessments include spirometry (FVC, DLCO), thoracic CT fibrosis, echocardiography (LVEF, global longitudinal strain), cardiac MRI, and SHAQ score

  27. Change in the lung capacity FVC (forced vital capacity)

    Time frame: From 3 months to 1 month before CAR-T infusion

    To assess the impact of the treatment on pulmonary function, FVC will be assessed during functionnal exploration test lab and we will evaluate the improvement in FVC over time

  28. Change in the lung capacity FVC (forced vital capacity)

    Time frame: 1 month before CAR-T infusion

    To assess the impact of the treatment on pulmonary function, FVC will be assessed during functionnal exploration test lab and we will evaluate the improvement in FVC over time

  29. Change in the lung capacity FVC (forced vital capacity)

    Time frame: 3 Months

    To assess the impact of the treatment on pulmonary function, FVC will be assessed during functionnal exploration test lab and we will evaluate the improvement in FVC over time

  30. Change in the lung capacity FVC (forced vital capacity)

    Time frame: 6 Months

    To assess the impact of the treatment on pulmonary function, FVC will be assessed during functionnal exploration test lab and we will evaluate the improvement in FVC over time

  31. Change in the lung capacity FVC (forced vital capacity)

    Time frame: 12 Months

    To assess the impact of the treatment on pulmonary function, FVC will be assessed during functionnal exploration test lab and we will evaluate the improvement in FVC over time

  32. Change in the lung capacity FVC (forced vital capacity)

    Time frame: 24 Months

    To assess the impact of the treatment on pulmonary function, FVC will be assessed during functionnal exploration test lab and we will evaluate the improvement in FVC over time

  33. Change in DLCO (diffusing capacity of the lung for carbon monoxide)

    Time frame: From 3 months to 1 month before CAR-T infusion

    The efficacy of the treatment on pulmonary function will also be analyzed by monitoring changes in DLCO (diffusing capacity of the lung for carbon monoxide), quantifiy during functionnal exploration test lab

  34. Change in DLCO (diffusing capacity of the lung for carbon monoxide)

    Time frame: 1 month before CAR-T infusion

    The efficacy of the treatment on pulmonary function will also be analyzed by monitoring changes in DLCO (diffusing capacity of the lung for carbon monoxide), quantifiy during functionnal exploration test lab

  35. Change in DLCO (diffusing capacity of the lung for carbon monoxide)

    Time frame: 3 Months

    The efficacy of the treatment on pulmonary function will also be analyzed by monitoring changes in DLCO (diffusing capacity of the lung for carbon monoxide), quantifiy during functionnal exploration test lab

  36. Change in DLCO (diffusing capacity of the lung for carbon monoxide)

    Time frame: 6 Months

    The efficacy of the treatment on pulmonary function will also be analyzed by monitoring changes in DLCO (diffusing capacity of the lung for carbon monoxide), quantifiy during functionnal exploration test lab

  37. Change in DLCO (diffusing capacity of the lung for carbon monoxide)

    Time frame: 12 Months

    The efficacy of the treatment on pulmonary function will also be analyzed by monitoring changes in DLCO (diffusing capacity of the lung for carbon monoxide), quantifiy during functionnal exploration test lab

  38. Change in DLCO (diffusing capacity of the lung for carbon monoxide)

    Time frame: 24 Months

    The efficacy of the treatment on pulmonary function will also be analyzed by monitoring changes in DLCO (diffusing capacity of the lung for carbon monoxide), quantifiy during functionnal exploration test lab

  39. Extent of fibrosis on pulmonary CT (Computed Tomography)

    Time frame: From 3 months to 1 month before CAR-T infusion

    Pulmonary response will be also assessment by CT scan and expressed as percentage of parenchyma affected. The type of parenchymal involvement willbe specified (ground glass, honeycomb)

  40. Extent of fibrosis on pulmonary CT(Computed Tomography)

    Time frame: 3 Months

    Pulmonary response will be also assessment by CT scan and expressed as percentage of parenchyma affected. The type of parenchymal involvement willbe specified (ground glass, honeycomb)

  41. Extent of fibrosis on pulmonary CT(Computed Tomography)

    Time frame: 12 Months

    Pulmonary response will be also assessment by CT scan and expressed as percentage of parenchyma affected. The type of parenchymal involvement willbe specified (ground glass, honeycomb)

  42. Extent of fibrosis on pulmonary CT(Computed Tomography)

    Time frame: 24 Months

    Pulmonary response will be also assessment by CT scan and expressed as percentage of parenchyma affected. The type of parenchymal involvement willbe specified (ground glass, honeycomb)

  43. Change in cardiac ejection fraction and global longitudinal strain

    Time frame: From 3 months to 1 month before CAR-T infusion

    A transthoracic cardiac ultrasound will be performed regularly to assess the effect of treatment on the left ventricular ejection fraction, as well as the global longitudinal strain (GLS).

  44. Change in cardiac ejection fraction and global longitudinal strain

    Time frame: 3 Months

    A transthoracic cardiac ultrasound will be performed regularly to assess the effect of treatment on the left ventricular ejection fraction, as well as the global longitudinal strain (GLS).

  45. Change in cardiac ejection fraction and global longitudinal strain

    Time frame: 12 Months

    A transthoracic cardiac ultrasound will be performed regularly to assess the effect of treatment on the left ventricular ejection fraction, as well as the global longitudinal strain (GLS).

  46. Change in cardiac ejection fraction and global longitudinal strain

    Time frame: 24 Months

    A transthoracic cardiac ultrasound will be performed regularly to assess the effect of treatment on the left ventricular ejection fraction, as well as the global longitudinal strain (GLS).

  47. Cardiomyopathy, change in cardiac MRI (Magnetic Resonance Imaging) signal

    Time frame: From 3 months to 1 month before CAR-T infusion

    A cardiac MRI (Magnetic Resonance Imaging) will be performed at baseline and at follow-up visit to evaluate the effect of treatment on T1 and T2 mapping, late gadolinium enhancement (LGE), extracellular volume ( ECV) mapping and indirect indicators of pulmonary hypertension

  48. Cardiomyopathy, change in cardiac MRI (Magnetic Resonance Imaging) signal

    Time frame: 12 Months

    A cardiac MRI (Magnetic Resonance Imaging) will be performed at baseline and at follow-up visit to evaluate the effect of treatment on T1 and T2 mapping, late gadolinium enhancement (LGE), extracellular volume ( ECV) mapping and indirect indicators of pulmonary hypertension

  49. Cardiomyopathy, change in cardiac MRI (Magnetic Resonance Imaging) signal

    Time frame: 24 Months

    A cardiac MRI (Magnetic Resonance Imaging) will be performed at baseline and at follow-up visit to evaluate the effect of treatment on T1 and T2 mapping, late gadolinium enhancement (LGE), extracellular volume ( ECV) mapping and indirect indicators of pulmonary hypertension

  50. Change in scleroderma-adapted Scleroderma Health Assessment Questionnaire (SHAQ) score

    Time frame: Day 0 (CAR-T infusion)

    Clinical response will be assessed using SHAQ : the patient will complete a self-assessment questionnaire on their health status during systemic sclerosis (SSc) and we will compare the scores at each stage

  51. Change in scleroderma-adapted Scleroderma Health Assessment Questionnaire (SHAQ) score

    Time frame: Day 28 after CAR-T cell infusion

    Clinical response will be assessed using SHAQ : the patient will complete a self-assessment questionnaire on their health status during systemic sclerosis (SSc) and we will compare the scores at each stage

  52. Change in scleroderma-adapted Scleroderma Health Assessment Questionnaire (SHAQ) score

    Time frame: 3 Months

    Clinical response will be assessed using SHAQ : the patient will complete a self-assessment questionnaire on their health status during systemic sclerosis (SSc) and we will compare the scores at each stage

  53. Change in scleroderma-adapted Scleroderma Health Assessment Questionnaire (SHAQ) score

    Time frame: 6 Months

    Clinical response will be assessed using SHAQ : the patient will complete a self-assessment questionnaire on their health status during systemic sclerosis (SSc) and we will compare the scores at each stage

  54. Change in scleroderma-adapted Scleroderma Health Assessment Questionnaire (SHAQ) score

    Time frame: 12 Months

    Clinical response will be assessed using SHAQ : the patient will complete a self-assessment questionnaire on their health status during systemic sclerosis (SSc) and we will compare the scores at each stage

  55. Change in scleroderma-adapted Scleroderma Health Assessment Questionnaire (SHAQ) score

    Time frame: 24 Months

    Clinical response will be assessed using SHAQ : the patient will complete a self-assessment questionnaire on their health status during systemic sclerosis (SSc) and we will compare the scores at each stage

  56. Change in Health Assessment Questionnaire Disability Index HAQ-DI score

    Time frame: Day 0 (CAR-T cell infusion)

    The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a quantitative tool used to measure health related quality of life assessments related to SSc ; Clinical response will be assessed using HAQ-DI and we will compare the scores at each stage

  57. Change in Health Assessment Questionnaire Disability Index HAQ-DI score

    Time frame: Day 28 after CAR-T cell infusion

    The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a quantitative tool used to measure health related quality of life assessments related to SSc ; Clinical response will be assessed using HAQ-DI and we will compare the scores at each stage

  58. Change in Health Assessment Questionnaire Disability Index HAQ-DI score

    Time frame: 3 Months

    The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a quantitative tool used to measure health related quality of life assessments related to SSc ; Clinical response will be assessed using HAQ-DI and we will compare the scores at each stage

  59. Change in Health Assessment Questionnaire Disability Index HAQ-DI score

    Time frame: 6 Months

    The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a quantitative tool used to measure health related quality of life assessments related to SSc ; Clinical response will be assessed using HAQ-DI and we will compare the scores at each stage

  60. Change in Health Assessment Questionnaire Disability Index HAQ-DI score

    Time frame: 12 Months

    The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a quantitative tool used to measure health related quality of life assessments related to SSc ; Clinical response will be assessed using HAQ-DI and we will compare the scores at each stage

  61. Change in Health Assessment Questionnaire Disability Index HAQ-DI score

    Time frame: 24 Months

    The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a quantitative tool used to measure health related quality of life assessments related to SSc ; Clinical response will be assessed using HAQ-DI and we will compare the scores at each stage

  62. Change in Health Assessment Questionnaire Cochin Hand score

    Time frame: Day 0 (CAR-T cell infusion)

    Clinical response will also be assessed using the Cochin Hand Function Scale, a validated tool that quantifies disability resulting from hand functional impairment.

  63. Change in Health Assessment Questionnaire Cochin Hand score

    Time frame: Day 28 after CAR-T cell infusion

    Clinical response will also be assessed using the Cochin Hand Function Scale, a validated tool that quantifies disability resulting from hand functional impairment.

  64. Change in Health Assessment Questionnaire Cochin Hand score

    Time frame: 3 Months

    Clinical response will also be assessed using the Cochin Hand Function Scale, a validated tool that quantifies disability resulting from hand functional impairment.

  65. Change in Health Assessment Questionnaire Cochin Hand score

    Time frame: 6 Months

    Clinical response will also be assessed using the Cochin Hand Function Scale, a validated tool that quantifies disability resulting from hand functional impairment.

  66. Change in Health Assessment Questionnaire Cochin Hand score

    Time frame: 12 Months

    Clinical response will also be assessed using the Cochin Hand Function Scale, a validated tool that quantifies disability resulting from hand functional impairment.

  67. Change in Health Assessment Questionnaire Cochin Hand score

    Time frame: 24 Months

    Clinical response will also be assessed using the Cochin Hand Function Scale, a validated tool that quantifies disability resulting from hand functional impairment.

  68. Change in quality of life Questionnaire SF-36

    Time frame: Day 0 (CAR-T cell infusion)

    Clinical response will also be assessed using the SF36 score collected at each time point through the SF36 self-assessment questionnaire, which evaluates the patient's quality of life across eight domains, including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health

  69. Change in quality of life Questionnaire SF-36

    Time frame: Day 28 after CAR-T cell infusion

    Clinical response will also be assessed using the SF36 score collected at each time point through the 36-Item Short Form Survey (SF-36) self-assessment questionnaire, which evaluates the patient's quality of life across eight domains, including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health

  70. Change in quality of life Questionnaire SF-36

    Time frame: 3 Months

    Clinical response will also be assessed using the SF36 score collected at each time point through the 36-Item Short Form Survey (SF-36) self-assessment questionnaire, which evaluates the patient's quality of life across eight domains, including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health

  71. Change in quality of life Questionnaire SF-36

    Time frame: 6 Months

    Clinical response will also be assessed using the SF36 score collected at each time point through the 36-Item Short Form Survey (SF-36) self-assessment questionnaire, which evaluates the patient's quality of life across eight domains, including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health

  72. Change in quality of life Questionnaire SF-36

    Time frame: 12 Months

    Clinical response will also be assessed using the SF36 score collected at each time point through the 36-Item Short Form Survey (SF-36) self-assessment questionnaire, which evaluates the patient's quality of life across eight domains, including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health

  73. Change in quality of life Questionnaire SF-36

    Time frame: 24 Months

    Clinical response will also be assessed using the SF36 score collected at each time point through the 36-Item Short Form Survey (SF-36) self-assessment questionnaire, which evaluates the patient's quality of life across eight domains, including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health

  74. Change in the university of California Los Angeles scleroderma clinical trials consortium gastrointestinal tract (ULCA-SCTC GIT) score

    Time frame: Day 0 (CAR-T cell infusion)

    to evaluate disease response on to systemic sclerosis associated gastrointestinal tract symptoms severity and its impact on patients' well-being, we will compare ULCA-SCTC GIT Score, which is a self-administered questionnaire completed at each time point

  75. Change in the university of California Los Angeles scleroderma clinical trials consortium gastrointestinal tract (ULCA-SCTC GIT) score

    Time frame: Day 28 after CAR-T cell infusion

    to evaluate disease response on to systemic sclerosis associated gastrointestinal tract symptoms severity and its impact on patients' well-being, we will compare ULCA-SCTC GIT Score, which is a self-administered questionnaire completed at each time point

  76. Change in the university of California Los Angeles scleroderma clinical trials consortium gastrointestinal tract (ULCA-SCTC GIT) score

    Time frame: 3 Months

    to evaluate disease response on to systemic sclerosis associated gastrointestinal tract symptoms severity and its impact on patients' well-being, we will compare ULCA-SCTC GIT Score, which is a self-administered questionnaire completed at each time point

  77. Change in the university of California Los Angeles scleroderma clinical trials consortium gastrointestinal tract (ULCA-SCTC GIT) score

    Time frame: 6 Months

    to evaluate disease response on to systemic sclerosis associated gastrointestinal tract symptoms severity and its impact on patients' well-being, we will compare ULCA-SCTC GIT Score, which is a self-administered questionnaire completed at each time point

  78. Change in the university of California Los Angeles scleroderma clinical trials consortium gastrointestinal tract (ULCA-SCTC GIT) score

    Time frame: 12 Months

    to evaluate disease response on to systemic sclerosis associated gastrointestinal tract symptoms severity and its impact on patients' well-being, we will compare ULCA-SCTC GIT Score, which is a self-administered questionnaire completed at each time point

  79. Change in the university of California Los Angeles scleroderma clinical trials consortium gastrointestinal tract (ULCA-SCTC GIT) score

    Time frame: 24 Months

    to evaluate disease response on to systemic sclerosis associated gastrointestinal tract symptoms severity and its impact on patients' well-being, we will compare ULCA-SCTC GIT Score, which is a self-administered questionnaire completed at each time point

  80. Change in Malnutrition Universal Screening Tool (MUST) score

    Time frame: From 3 months to 1 month before CAR-T cell infusion

    We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake

  81. Change in Malnutrition Universal Screening Tool (MUST) score

    Time frame: 1 month before CAR-T cell infusion

    We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake

  82. Change in Malnutrition Universal Screening Tool (MUST) score

    Time frame: Day 0 (CAR-T cell infusion)

    We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake

  83. Change in Malnutrition Universal Screening Tool (MUST) score

    Time frame: Day 28 after CAR-T cell infusion

    We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake

  84. Change in Malnutrition Universal Screening Tool (MUST) score

    Time frame: 3 Months

    We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake

  85. Change in Malnutrition Universal Screening Tool (MUST) score

    Time frame: 6 Months

    We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake

  86. Change in Malnutrition Universal Screening Tool (MUST) score

    Time frame: 12 Months

    We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake

  87. Change in Malnutrition Universal Screening Tool (MUST) score

    Time frame: 24 Months

    We will also assess the effect of treatment on digestive impairment in scleroderma patient, as well as their risk of malnutrition, using the MUST score. This evaluation includes measuring the percentage of weight loss over the previous 3 to 6 months, calculating body mass index, and determining whether the patient has been seriously ill and experienced a period of more than 5 days without nutritional intake

  88. Anti-antibody titers

    Time frame: From 3 months to 1 month before CAR-T cell infusion

    Measurement of antinuclear antibodies (ANA), anti-centromere, anti-DNA, anti-Topoisomerase, and TRAK antibody titers following CAR T anti-CD19 cell administration

  89. Anti-antibody titers

    Time frame: Day 28 after CAR-T cell infusion

    Measurement of antinuclear antibodies (ANA), anti-centromere, anti-DNA, anti-Topoisomerase, and TRAK antibody titers following CAR T anti-CD19 cell administration

  90. Anti-antibody titers

    Time frame: 6 Months

    Measurement of antinuclear antibodies (ANA), anti-centromere, anti-DNA, anti-Topoisomerase, and TRAK antibody titers following CAR T anti-CD19 cell administration

  91. Anti-antibody titers

    Time frame: 12 Months

    Measurement of antinuclear antibodies (ANA), anti-centromere, anti-DNA, anti-Topoisomerase, and TRAK antibody titers following CAR T anti-CD19 cell administration

  92. CAR T cell counts

    Time frame: Day 0 (CAR-T cell infusion)

    Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion

  93. CAR T cell counts

    Time frame: Day 4 after CAR-T cell infusion

    Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion

  94. CAR T cell counts

    Time frame: Day 7 after CAR-T cell infusion

    Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion

  95. CAR T cell counts

    Time frame: Day 10 after CAR-T cell infusion

    Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion

  96. CAR T cell counts

    Time frame: Day 14 after CAR-T cell infusion

    Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion

  97. CAR T cell counts

    Time frame: Day 21 after CAR-T cell infusion

    Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion

  98. CAR T cell counts

    Time frame: Day 28 after CAR-T cell infusion

    Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion

  99. CAR T cell counts

    Time frame: 3 Months

    Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion

  100. CAR T cell counts

    Time frame: 6 Months

    Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion

  101. CAR T cell counts

    Time frame: 12 Months

    Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion

  102. CAR T cell counts

    Time frame: 24 Months

    Quantification of CAR T cells using flow cytometry and qPCR to assess expansion and persistence after CAR T anti-CD19 infusion

  103. Immunophenotyping of B, T, and NK cells subsets

    Time frame: Day -14 (14 days before CAR-T infusion)

    Immunophenotyping of B cells, T cells, NK cells, and immune subpopulations to evaluate immune reconstitution following CAR T infusion

  104. Immunophenotyping of B, T, and NK cells subsets

    Time frame: Day 28 after CAR-T cell infusion

    Immunophenotyping of B cells, T cells, NK cells, and immune subpopulations to evaluate immune reconstitution following CAR T infusion

  105. Immunophenotyping of B, T, and NK cells subsets

    Time frame: 3 Months

    Immunophenotyping of B cells, T cells, NK cells, and immune subpopulations to evaluate immune reconstitution following CAR T infusion

  106. Immunophenotyping of B, T, and NK cells subsets

    Time frame: 6 Months

    Immunophenotyping of B cells, T cells, NK cells, and immune subpopulations to evaluate immune reconstitution following CAR T infusion

  107. Immunophenotyping of B, T, and NK cells subsets

    Time frame: 12 Months

    Immunophenotyping of B cells, T cells, NK cells, and immune subpopulations to evaluate immune reconstitution following CAR T infusion

  108. B-cell receptor (BCR) repertoire analysis

    Time frame: Day -14 (14 days before CAR-T infusion)

    BCR repertoire analysis performed on B cells from Systemic Sclerosis (SSc) patients. Assessment occurs at Month 6 if B-cell percentage is >50% of baseline; otherwise at Month 12 after CAR T anti-CD19 administration

  109. B-cell receptor (BCR) repertoire analysis

    Time frame: 6 Months

    BCR repertoire analysis performed on B cells from Systemic Sclerosis (SSc) patients. Assessment occurs at Month 6 if B-cell percentage is >50% of baseline; otherwise at Month 12 after CAR T anti-CD19 administration

  110. B-cell receptor (BCR) repertoire analysis

    Time frame: 12 Months

    BCR repertoire analysis performed on B cells from Systemic Sclerosis (SSc) patients. Assessment occurs at Month 6 if B-cell percentage is >50% of baseline; otherwise at Month 12 after CAR T anti-CD19 administration

  111. B-cell receptor (BCR) repertoire analysis

    Time frame: 24 Months

    BCR repertoire analysis performed on B cells from Systemic Sclerosis (SSc) patients. Assessment occurs at Month 6 if B-cell percentage is >50% of baseline; otherwise at Month 12 after CAR T anti-CD19 administration

  112. Skin biopsies for single-cell phenotyping

    Time frame: From 3 months to 1 month before CAR-T infusion

    Skin biopsies (for patients who have given their consent) performed at baseline for single-cell phenotyping analyses.

  113. Skin biopsies for single-cell phenotyping

    Time frame: 3 Months

    Skin biopsies (for patients who have given their consent) performed at M3 for single-cell phenotyping analyses.

  114. lymph node biopsies for single-cell phenotyping

    Time frame: 3 Months

    lymph node biopsies (for patients who have given their consent) performed at Month 3 for single-cell phenotyping analyses.

  115. Incidence rate of adverse events

    Time frame: Day -14 to 24 months

    Incidence rate of adverse events graded according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 and classified following the American Society of Clinical Oncology (ASCO) guidelines

  116. Incidence of Cytokine Release Syndrome (CRS)

    Time frame: Day -14 to 24 months

    Incidence and severity of Cytokine Release Syndrome (CRS), graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading system.

  117. Incidence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

    Time frame: Day -14 to 24 months

    Incidence and severity of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading system

  118. Incidence of Cytopenias

    Time frame: Day -14 to 24 months

    Incidence and severity of cytopenias, graded according to the consensus grading system of the European Hematology Association (EHA) and the European Society for Blood and Marrow Transplantation (EBMT) consensus grading system

  119. Incidence of Infections

    Time frame: Day -14 to 24 months

    Incidence and severity of infections, graded according to Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

  120. Incidence of Cardiac Events

    Time frame: Day -14 to 24 months

    Incidence and severity of cardiac adverse events, graded according to Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

  121. Incidence of Acute Kidney Injury

    Time frame: Day -14 to 24 months

    Incidence and severity of acute kidney injury, graded according to Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

  122. Incidence of Scleroderma Renal Crisis

    Time frame: Day -14 to 24 months

    Incidence of clinically diagnosed scleroderma renal crisis

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte KAAN

CONTACT

[email protected]

04 67 33 48 53 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

SCLEROCAR: A Phase IIa Trial Evaluating the Efficacy of Anti-CD19 Chimeric Antigen Receptor Engineered T-Cells in Patients With Systemic Sclerosis (SSc) Resistant to Immunosuppressive Drugs

Acronym: SCLEROCAR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 25, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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