Study of RD06-05 Anti-CD19BCMA Universal CAR-T Cell Therapy for Autoimmune Diseases Evaluating Safety, Effectiveness, and Cell Behavior

What this Trial Is About

Researchers are evaluating a new anti-CD19BCMA universal CAR-T cell therapy called RD06-05 in adults with various autoimmune diseases, including systemic lupus erythematosus SLE, lupus nephritis LN, ANCA-associated vasculitis AAV, anti-GBM disease, membranous nephropathy MN, systemic sclerosis SSc, idiopathic inflammatory myopathy IIM, and IgA nephropathy. This early phase 1, open-label, single-arm study aims to explore the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of this investigational cell therapy. Participants will receive the RD06-05 CAR T-cell therapy through an intravenous infusion following a preparatory lymphodepleting regimen using fludarabine and cyclophosphamide. The dose escalation design allows careful assessment of safety and biological effects. The study is planned to last up to approximately three years, with primary safety outcome monitoring over 2 years after treatment. During the study, participants will be closely monitored for adverse events, including treatment-emergent and serious side effects, as well as specific safety concerns related to cell therapy. Researchers will evaluate the therapys impact on disease activity and organ function through clinical assessments and laboratory tests. Participants will be followed for safety and efficacy outcomes until the study ends, expected in July 2028, with regular visits scheduled according to the study protocol.

A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.