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NCT Number: NCT06249438

A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy

This is an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy

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Key information

Conditions

Systemic Lupus Erythematosus (SLE) Autoimmune Diseases Autoimmune Diseases of the Nervous System Connective Tissue Diseases Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Immune-mediated Necrotizing Myopathy (IMNM) Lupus Erythematosus, Systemic Multiple Sclerosis Multiple Sclerosis (MS) Myasthenia Gravis Myelitis, Transverse Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorders (NMOSD) Optic Nerve Diseases Optic Neuritis Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Systemic Sclerosis (SSc)

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University

Shanghai, Shanghai Municipality, 200001, China

Location status: Recruiting

Location contact

Huihua Ding, MD

CONTACT

[email protected]

+86-21-53882280

Huihua Ding, MD

PRINCIPAL_INVESTIGATOR

Nan Shen, MD & PhD

CONTACT

[email protected]

+86-21-63260477

Nan Shen, MD & PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 to 70 years old at the time of signing the Informed Consent Form (ICF).
  • Diagnosed as SLE/Immune-Mediated Necrotizing Myopathy (IMNM)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Multiple Sclerosis (MS)/Myasthenia Gravis (MG)/Systemic Sclerosis (SSc) according to recognized diagnostic criteria for at least 6 months.
  • Remains disease active or relapses after treatment with standard of care therapy for at least 8 weeks with the dose stable for more than 2 weeks; patients should have been treated with at least two immunosuppressants (including immunosuppressants, biologics, and disease-modifying drug (DMD) ).
  • Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.

Exclusion criteria

  • Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive, Epstein-Barr Virus (EBV) DNA positive.
  • Uncontrolled active infection.
  • Live vaccine injection within 4 weeks prior to signing the ICF.
  • Major organ transplantation history or bone marrow/hematopoietic stem cell transplantation history.
  • Severe cardiovascular diseases within the past 6 months prior to screening.
  • ≥ Grade 2 bleeding within the past 30 days prior to screening, or requiring long-term anticoagulants treatment.
  • Inadequate washing time for previous treatment.
  • Previously treated with CAR-T cell products or genetically modified T cell therapies.
  • Pregnant or lactating women.
  • Severe central nervous system diseases or pathological changes.
  • Malignancy history within 5 years prior to signing the ICF.

Treatment and study plan

CD20/BCMA-directed CAR-T cells

Biological

Autologous 2nd generation CD20/BCMA-directed CAR-T cells, single infusion intravenously

Other names: C-CAR168

Primary outcomes

  1. Incidence of Adverse Events [Safety and Tolerability]

    Time frame: Throughout the first 24 months follow up period completion (3 years)，DLTs will be observed/collected throughout the 28 days post C-CAR168 infusion

    Incidence of any adverse events (AEs), including dose limiting toxicities (DLTs)

  2. The subsequent recommended dose of C-CAR168 in patients with autoimmune diseases refractory to standard therapy

    Time frame: Throughout the first 24 months follow up period completion (3 years)

    Based on the assessment of dose-limiting toxicities (DLTs) rates and overall safety profile

Secondary outcomes

  1. The proportion of subjects who achieved remission at 6 months (6M)

    Time frame: Throughout the first 6 months follow up period completion (1.5 years)

  2. The proportion of subjects who achieved remission during the main study period

    Time frame: Throughout the first 24 months follow up period completion (3 years)

  3. The proportion of subjects who experienced relapse during the main study period

    Time frame: Throughout the first 24 months follow up period completion (3 years)

  4. Time to response (TTR)

    Time frame: Throughout the first 24 months follow up period completion (3 years)

    The time from the date of C-CAR168 infusion to the first documented remission

  5. Progression-free survival (PFS)

    Time frame: Throughout the first 24 months follow up period completion (3 years)

    The time from the date of C-CAR168 infusion to the date of first documented disease progression or death, whichever comes first

  6. The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period

    Time frame: Throughout the first 24 months follow up period completion (3 years)

  7. Maximal plasma concentration (Cmax)

    Time frame: Throughout the first 24 months follow up period completion (3 years)

    Maximal plasma concentration of C-CAR168 in peripheral blood

  8. Time to reach the maximal plasma concentration (Tmax)

    Time frame: Throughout the first 24 months follow up period completion (3 years)

    Time to reach the maximal plasma concentration of C-CAR168 in peripheral blood

  9. Duration in peripheral blood (Tlast)

    Time frame: Throughout the first 24 months follow up period completion (3 years)

    The duration of C-CAR168 in peripheral blood

  10. Area under curve (AUC)

    Time frame: Throughout the first 24 months follow up period completion (3 years)

    Area under the curve of C-CAR168 in peripheral blood

  11. The clearance of peripheral blood B cell

    Time frame: Throughout the first 24 months follow up period completion (3 years)

  12. The decline of serum immunoglobulin

    Time frame: Throughout the first 24 months follow up period completion (3 years)

  13. The elevation of peripheral blood complement

    Time frame: Throughout the first 24 months follow up period completion (3 years)

  14. The decline of autoantibodies or other disease specific biomarkers

    Time frame: Throughout the first 24 months follow up period completion (3 years)

Other outcomes

  1. Serum cytokines (including Interleukin (IL)-2, IL-4, IL-6, IL-10, Tumor Necrosis Factor (TNF)-α, Interferon (IFN)-γ) changes

    Time frame: Throughout the first 24 months follow up period completion (3 years)

    Detection of serum cytokines (including IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ) changes over time by flow cytometry

  2. Soluble BCMA changes in peripheral blood

    Time frame: Throughout the first 24 months follow up period completion (3 years)

    Detection of soluble BCMA changes in peripheral blood by Enzyme Linked ImmunoSorbent Assay (ELISA)

  3. RNA changes in peripheral blood

    Time frame: Throughout the first 24 months follow up period completion (3 years)

    Detection of RNA changes in peripheral blood by RNA sequencing

  4. Protective antibodies changes in peripheral blood

    Time frame: Throughout the first 24 months follow up period completion (3 years)

    Detection of protective antibodies changes in peripheral blood by ELISA

  5. B cells changes in bone marrow, skin, muscle or kidney

    Time frame: Throughout the first 24 months follow up period completion (3 years)

    Detection of B cells concentration changes in bone marrow, skin, muscle or kidney by flow cytometry

  6. Plasma cells or long-lived plasma cells changes in bone marrow, skin, muscle or kidney

    Time frame: Throughout the first 24 months follow up period completion (3 years)

    Detection of plasma cells or long-lived plasma cells concentration changes in bone marrow, skin, muscle or kidney by flow cytometry

Study contacts

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

Huihua Ding, MD

CONTACT

[email protected]

+86-21-53882280

Nan Shen, MD & PhD

CONTACT

[email protected]

+86-21-63260477

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • AbelZeta Inc.

Registry information

Official study title

An Exploratory Clinical Study of Cluster of Differentiation Antigen 20(CD20)/Anti-B-cell Maturation Antigen(BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Autoimmune Diseases Refractory to Standard Therapy

Acronym: CAR-AID

Important dates

Study start
2024
Primary completion
2027
Study completion
2040
First posted
Feb 8, 2024
Registry last updated
Jul 25, 2025

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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