Study of CD19BCMA-targeted CAR-T Therapy to Assess Safety and Early Effectiveness in Adults with Hard-to-Treat Autoimmune Diseases

What this Trial Is About

Researchers are evaluating the safety, tolerability, and initial effectiveness of CD19BCMA-targeted CAR-T cell therapy in patients with refractory autoimmune diseases. This early exploratory, open-label, single-arm clinical study focuses on adults aged 18 to 70 who have autoimmune conditions that have not responded to standard treatments. The study aims to explore whether this new in vivo CAR-T therapy approach can control disease activity without prior lymphodepletion. Participants will receive an intravenous infusion of the CD19BCMA-targeted CAR-T lentiviral vector drug. After infusion, the CAR-T cells are produced directly inside the patients body. No lymphodepleting chemotherapy will be given before treatment. Following the infusion, participants will be monitored for safety and efficacy over a 24-month period to assess disease control and treatment tolerability. During the study, participants will undergo regular safety assessments to monitor adverse events at multiple time points including Day 28, and Months 2, 3, 6, 12, 18, and 24. Researchers will track the maximum tolerated dose within 28 days after infusion. Additional evaluations will include clinical and laboratory tests to assess disease response and patient health. The total participation length can be up to two years, allowing long-term observation of treatment effects and safety.

A Clinical Study of the Safety, Tolerability and Preliminary Efficacy of CD19/BCMA-targeted CAR-T Therapy in Refractory Autoimmune Diseases