eligibility_summary
Adults ≥18 with primary ITP ≥3 months, steroid-failure but prior response, platelets <30×10^9/L on ≥2 tests, ECOG ≤2. One stable ITP concomitant allowed, contraception, consent. Exclude: anti‑CD38 allergy/inefficacy, secondary ITP/AIHA, recent thrombosis/major bleed, recent trials/anticoagulants/emergency ITP meds/immunosuppressants, splenectomy <6 mo, live vaccines, MDS/cancer <5y, transplant, serious comorbidities/infections/immunosuppression, lab abnl (AST/ALT>3xULN, TBil>1.5x, ANC<1500, Hb<9, IgG<500, lymph<500, CrCl<30), HIV/syphilis, active HBV/HCV, pregnancy, other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, randomized, double-blind, placebo-controlled trial in adults with primary immune thrombocytopenia (ITP) refractory to glucocorticoids tests CM313, an anti-CD38 monoclonal antibody (IV 16 mg/kg weekly for 8 weeks) vs placebo. Drug type: therapeutic monoclonal antibody. Mechanism: binds CD38 to target and deplete CD38+ long-lived plasma cells (and plasmablasts), the presumed source of pathogenic antiplatelet autoantibodies. Intended effect: reduce autoantibody production, thereby decreasing platelet destruction and improving platelet production by megakaryocytes. Cells/pathways targeted: CD38-expressing plasma cells, humoral autoimmunity/autoantibody pathway in ITP. Comparator: placebo infusions on the same schedule.