A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease

What this Trial Is About

Researchers are evaluating the safety and early effectiveness of a new CAR T-cell therapy using universal allogeneic anti-CD19/BCMA CAR T-cells in patients with B cell mediated autoimmune diseases. This Phase 1 clinical trial focuses on conditions such as systemic lupus erythematosus, multi-drug resistant nephrotic syndrome, IgA nephropathy, systemic sclerosis, and ANCA-associated vasculitis. The study aims to understand how this therapy impacts these autoimmune diseases by targeting specific B cells. Participants receive a single intravenous infusion of the universal CAR T-cells following a preparatory lymphodepleting treatment with cyclophosphamide. The study includes an initial treatment period with safety and efficacy assessments at 12 and 24 weeks after infusion. This therapy is being carefully monitored to evaluate dose-limiting toxicities and biological responses related to CAR T-cell presence and activity. Throughout the trial, participants will undergo various evaluations including monitoring of adverse events within 28 days post-infusion, pharmacokinetic assessments of CAR T-cells, and immunological markers such as B cell depletion and antibody changes up to 12 months. Safety and disease activity will be closely observed with follow-ups extending to assess long-term effects and treatment impact. The estimated total duration of participation varies per individual as the study progresses.

CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease