Study of CD19 CAR-T Cell Therapy for Adults with Tough-to-Treat Autoimmune Diseases

What this Trial Is About

Researchers are evaluating the safety and effectiveness of CD19 targeted CAR-T cell therapy in patients with refractory autoimmune diseases. This study focuses on conditions such as Systemic Lupus Erythematosus, Sjogrens Syndrome, Systemic Scleroderma, Dermatomyositis, and Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis. The goal is to verify the safety and therapeutic potential of this treatment for patients who have not responded to other therapies. The study involves a single infusion of CD19 targeted CAR-T cells administered intravenously. This is a phase 1 clinical trial conducted by Chongqing Precision Biotech Co., Ltd. Participants receive one dose of the CAR-T therapy, and the trial monitors both safety and disease response over time. Treatment effects on autoimmune symptoms and the ability to reduce or stop immunosuppressants and hormones are also evaluated. Participants will undergo regular assessments including safety monitoring for adverse events within the first month after infusion, and evaluations of disease activity over a three-month period. Researchers will measure cell dynamics, pharmacodynamics, and immunological changes up to two years to understand long-term effects. The trial includes clinical evaluations specific to each autoimmune disease and requires informed consent from participants.

Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease