C-CAR168 treatment for autoimmune diseases not responding to standard therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label study investigates the use of C-CAR168, a bi-specific CAR-T therapy targeting CD20 and BCMA, in adult patients suffering from autoimmune diseases that have not responded to standard treatments. Participants must have been diagnosed with conditions such as Systemic Lupus Erythematosus, Immune-Mediated Necrotizing Myopathy, and others for at least six months and must show active disease despite previous therapies. The study aims to evaluate the safety and efficacy of this innovative treatment approach in a Phase 1 setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Nan Shen, MD & PhD — Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University
• Study coordinator: Nan Shen, MD & PhD
• Email: nanshensibs@gmail.com
• Phone: +86-21-63260477

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.