eligibility_summary
Include: adults ≥18 with flow CD19+ or BCMA+ and AIHA, relapsed/refractory after ≥3 therapies (incl steroids/rituximab) with Hb<100 g/L, ECOG ≤2, adequate marrow, LFTs ≤3×ULN, Tbili ≤2× (≤3× Gilbert), CrCl ≥30. Contraception/neg HCG, consent. Exclude: severe allergy, uncontrolled infection, CNS/cardiac disease, Ig deficiency, cancer <5y, ESRD, HBV/HCV/HIV/syphilis, severe psych/cognitive issues, recent immunosuppressives, pregnancy, secondary AIHA (drug/lymphoproliferative), other unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, single-arm trial in refractory autoimmune hemolytic anemia evaluating a universal (off‑the‑shelf) allogeneic dual‑target CAR T‑cell therapy against CD19 and BCMA. Intervention: one IV infusion of anti‑CD19/BCMA CAR T cells after fludarabine/cyclophosphamide lymphodepletion. Type: cellular immunotherapy (gene‑modified T cells). Mechanism: CAR T cells bind CD19 and BCMA to kill B cells, plasmablasts, and plasma cells, depleting autoreactive antibody‑producing compartments. Targets/cells/pathways: CD19+ B cells, BCMA+ plasmablasts/plasma cells, B‑cell/autoantibody pathways driving hemolysis.