C-CAR168 treatment for autoimmune diseases not responding to standard therapy
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
This study is testing a new treatment called C-CAR168 to see if it can help adults with autoimmune diseases that haven't improved with standard therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06249438 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with specific autoimmune diseases that remain active despite standard therapies.
Not a fit: Patients with uncontrolled infections or certain viral infections like HIV or hepatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat autoimmune diseases.
How similar studies have performed: While CAR-T therapies have shown promise in hematological malignancies, their application in autoimmune diseases is still novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.