eligibility_summary
Eligible: ≥12 yrs with AIHA or Evans syndrome failing ≥3 lines (steroids, rituximab, plus ≥1 third-line), ECOG ≤2, life expectancy >3 mo, adequate organ/pulmonary function, negative HCG/contraception. Exclude: secondary/drug‑induced AIHA, Evans platelets <30×10^9/L, other lymphoid neoplasms, prior transplant or CAR‑T, recent specified therapies/surgery/live vaccine, active infection (HBV/HCV/HIV/TB), recent thrombosis, major heart/CNS disease, recent cancer, pregnancy/breastfeeding, other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, single-arm trial of CNCT19, an autologous second-generation anti‑CD19 CAR‑T cell therapy (cellular gene therapy) using an HI19α-derived scFv with 4‑1BB/CD3ζ costimulatory domains, in AIHA/Evans syndrome after ≥3 prior therapies. Mechanism: engineered T cells bind CD19 on B cells, receive 4‑1BB and CD3ζ activation, expand and cytotoxically eliminate CD19+ B cells/plasmablasts, reducing pathogenic autoantibody production. Targets: CD19+ B‑cell compartment and downstream autoantibody/complement-mediated hemolysis pathway, aiming to reset humoral autoimmunity. Primary goal: safety/tolerability with dose escalation, efficacy assessed after preconditioning.