Study of C-CAR168 CAR-T Therapy for Autoimmune Diseases Not Responding to Standard Treatments

What this Trial Is About

Researchers are evaluating C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, in adults with autoimmune diseases that have not responded to standard treatments. This Phase 1, investigator-initiated, multicenter, open-label study focuses on conditions such as Systemic Lupus Erythematosus, Immune-mediated Necrotizing Myopathy, Neuromyelitis Optica Spectrum Disorders, Multiple Sclerosis, Myasthenia Gravis, and Systemic Sclerosis. The study aims to assess the safety, tolerability, and optimal dosing of this new therapy in these patients. Participants receive a single intravenous infusion of the 2nd generation CD20/BCMA-directed CAR-T cells called C-CAR168. The treatment is administered once, and patients are monitored closely for side effects and responses. The trial includes a follow-up period lasting up to 24 months (3 years total), during which dose-limiting toxicities (DLTs) are observed for 28 days post-infusion, and further assessments continue to understand long-term effects and dosing recommendations. During the study, participants undergo various evaluations including monitoring for adverse events, remission rates, relapse occurrences, and measures of immune function such as plasma concentration of the therapy, blood B cell clearance, and changes in disease-specific biomarkers. These assessments occur repeatedly throughout the 24-month follow-up. The study also tracks glucocorticoid and immunosuppressant use to evaluate treatment impact. Safety and tolerability data are gathered continuously to guide future use and recommendations.

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