eligibility_summary
Adults (≥18) with primary Evans syndrome: DAT IgG+, active hemolysis, PLT<30×10^9/L or Hb<100 g/L/symptomatic anemia, refractory/relapsed after steroids plus ≥1 second-line (or ineligible), adequate hepatic/renal function, ECOG≤2, NYHA≤2, required washouts, consent. Exclude secondary ES, prior anti‑CD38, major organ failure/malignancy, HIV/active infections, severe bleeding, cardiovascular/thrombotic disease, transplants, unresolved toxicity, antiplatelets, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Anti‑CD38 monoclonal antibody (e.g., daratumumab), an IgG1 immunotherapy, given IV 16 mg/kg weekly for 8 weeks to adults with relapsed/refractory primary Evans syndrome. Mechanism of action: binds CD38 on plasma cells and depletes them via Fc‑mediated effector functions (ADCC, CDC, ADCP) and apoptosis, lowering production of pathogenic autoantibodies against red cells and platelets, may also modulate other CD38+ immune cells (e.g., NK, activated T/B cells). Targeted cells/pathways: long‑lived autoreactive plasma cells in bone marrow/spleen, humoral autoimmunity driving hemolysis and thrombocytopenia, complement and Fc effector pathways mediating cell clearance. Rationale: overcomes anti‑CD20 (rituximab) resistance by eliminating CD20‑negative plasma cells. Single‑arm, open‑label, phase 2 study (~10 patients, China).