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NCT Number: NCT07544225

Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases

This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced therapy medicinal product in adult patients; with severe and refractory systemic autoimmune rheumatic diseases, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren's disease (SjD), systemic sclerosis (SSc) and idiopathic inflammatory myositis (IIM).

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Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Idiopathic Inflammatory Myositis (IIM) Immune System Diseases Joint Diseases Lupus Erythematosus, Systemic Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Scleroderma, Systemic Sjogren's Disease With Dry Eyes Skin Diseases Skin and Connective Tissue Diseases Systemic Lupus Erythematosus (SLE) Systemic Sclerosis (SSc)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18-75 with ECOG PS 0-2 with written informed consent, valid health insurance, and eligibility for CAR T cell infusion are required may be included. Patients must have a treatment refractory systemic autoimmune rheumatic disease (RA, SLE, Sjögren's, SSc, or IIM) with severe, progressive activity with adequate renal function (creatinine clearance > 30 mL/min)

Exclusion criteria

  • Patients with any significant active infection, including hepatitis B or C, HIV, or other opportunistic or recurrent infections, are excluded. Prior gene therapy, previous CAR T treatment, active cancer within 2 years, or any history of allogeneic stem cell or solid organ transplantation exclude participation. Inadequate organ function-renal, hepatic, cardiac (LVEF < 50%), or lung function requiring oxygen- and uncontrolled comorbidities prevents inclusion. Pregnancy, breastfeeding, or refusal to use highly effective contraception for 12 months post infusion

Treatment and study plan

anti-CD19 CAR-T cells

Biological

The anti-CD19 CAR-T cells will be administered as a single infusion at the dose of 1x106 cells/kg body weight

Primary outcomes

  1. Unacceptable toxicities over a period of 4 weeks after the single CAR-T cell infusion

    Time frame: from CAR-T cells infusion to 30 days post-treatment

    Unacceptable toxicities are defined over a period of 4 weeks after the single CAR-T cell infusion as either:

    • Cytokine Release Syndrome (CRS) ≥ grade 3 or,
    • Immune-effector Cell Associated Neurotoxicity Syndrome (ICANS) ≥ grade 3 or,
    • Organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) ≥ grade 3

Study contacts

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

Cristina CASTILLA-LLORENTE

CONTACT

[email protected]

+33(0)142114355

Timothé DENAËS

CONTACT

[email protected]

+33(0)142115554

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Acronym: CELL-ATTACK 1

Important dates

Study start
2026
Primary completion
2029
Study completion
2043
First posted
Apr 22, 2026
Registry last updated
Apr 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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