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

Recruiting now · Phase 1

Conditions studied: Systemic Lupus Erythematosus (SLE), Immune-mediated Necrotizing Myopathy (IMNM), Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis (MS), Myasthenia Gravis, Systemic Sclerosis (SSc)

In brief

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

Key facts

Study ID

NCT06249438

Run by

RenJi Hospital

People needed

30

Starts

2024-03-20

Expected to finish

2040-03-01

Last updated by the study team

2025-07-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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