Study of Universal Allogeneic Anti-CD19BCMA CAR T-cell Therapy for Adults with Autoimmune Hemolytic Anemia Who Have Not Responded to at Least Three Treatments

What this Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of universal allogeneic anti-CD19BCMA CAR T-cells in adults with autoimmune hemolytic anemia AIHA who have not responded to three or more prior treatments. This Phase 1 clinical study focuses on patients who have undergone multiple therapies without success, aiming to understand the potential of this cellular therapy in difficult-to-treat AIHA cases. The treatment involves a single intravenous infusion of universal allogeneic CAR T-cells targeting CD19 and BCMA after patients receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide. Participants will be monitored closely, with an interim analysis planned at 12 weeks following the CAR T-cell infusion to assess safety and response. Participants will undergo assessments to track side effects, clinical response, and overall safety up to 24 weeks after treatment. Key measures include the number and severity of dose-limiting toxicities within 28 days, adverse events up to 12 months, and clinical response of AIHA up to 24 weeks post-infusion. The study requires informed consent and cooperation with follow-up evaluations throughout the monitoring period.

CAR T-cell Therapy Targeting CD19 and BCMA in Patients with AIHA Who Have Failed ≥3 Lines of Therapy.