Study of RD06-05 CAR-T Cell Therapy for Treating Autoimmune Diseases Including SLE, Systemic Sclerosis, AAV, IIM, NMOSD, MS, and MG in Adults

What this Trial Is About

Researchers are studying a new targeted CAR-T cell therapy called RD06-05 for adults with active autoimmune diseases including systemic lupus erythematosus SLE, systemic sclerosis SSc, ANCA-associated vasculitis AAV, idiopathic inflammatory myopathies IIM, neuromyelitis optica spectrum disorder NMOSD, multiple sclerosis MS, and myasthenia gravis MG. This early-phase clinical trial aims to evaluate the safety, tolerability, how the body processes the therapy, and its effects in these patients. The study is sponsored by Nanjing Bioheng Biotech Co., Ltd. Participants will receive RD06-05 CAR-T cell injections given intravenously after a preparatory lymphodepleting treatment with fludarabine and cyclophosphamide. The study includes careful monitoring over a two-year period to observe adverse events and other outcomes related to the treatment. The trial does not use placebo or masking, and all participants receive the experimental therapy. During the study, patients will undergo regular assessments including laboratory tests for liver, kidney, blood, and coagulation function, oxygen saturation, and heart function via echocardiography. Women of childbearing potential will have pregnancy tests and must use effective contraception. Researchers will track treatment safety by recording adverse events and will evaluate clinical disease activity using established criteria specific to each autoimmune condition. Participant involvement may last at least two years to monitor long-term effects and safety.

Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases