Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA for Adults with Relapsed or Refractory Autoimmune Diseases

What this Trial Is About

The trial is investigating universal allogeneic anti-CD19BCMA CAR T-cell therapy in adults with relapsed or refractory autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, inflammatory myopathy, ANCA-associated vasculitis, connective tissue disease-associated thrombocytopenia, and SLE-ITP. This phase 1 study aims to evaluate the safety and effectiveness of this treatment in patients who have not responded to conventional therapies. Participants receive a single intravenous infusion of the universal allogeneic CAR T-cells following a lymphodepleting chemotherapy regimen with fludarabine and cyclophosphamide. The study includes interim analyses at 12 and 24 weeks post-infusion to assess patient response and safety. The research focuses on monitoring dose-limiting toxicities, adverse events, and clinical responses during the treatment period. During the trial, participants will be closely monitored through scheduled visits and assessments to evaluate toxicity and treatment response up to 24 months after infusion. Researchers will measure the number and severity of dose-limiting toxicities within 28 days, adverse events up to 12 months, and clinical response of autoimmune diseases for up to 24 months. Participants are expected to comply with contraception requirements and follow-up visits throughout the study duration.

CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases