eligibility_summary
Include: age 6–18, primary ITP ≥3 months, failed steroids but prior response to GC/IVIG, platelets <30×10^9/L on 2 checks, ECOG ≤2. One stable maintenance (≤0.5 mg/kg prednisone or TPO‑RA) allowed. Require negative pregnancy test/contraception, consent. Exclude: anti‑CD38 issues, secondary ITP/AIHA, serious recent thrombosis/bleeding/infection, recent antiplatelets/ITP or investigational therapy, live vaccines, splenectomy, major comorbidity, abnormal labs, HIV/syphilis/HBV/HCV, pregnancy, prior transplant, malignancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm, open-label trial in China evaluating daratumumab (anti-CD38 monoclonal antibody, human IgG1κ biologic) given IV 16 mg/kg weekly for 4 doses in children (6–18) with steroid-refractory or -dependent primary ITP. Mechanism: binds CD38 on plasma cells/plasmablasts and depletes them via Fc-mediated effector functions (ADCC/ADCP), complement-dependent cytotoxicity (CDC), and apoptosis. Therapeutic aim: eliminate long-lived autoreactive plasma cells that produce anti-platelet antibodies, reducing antibody-mediated platelet destruction and supporting platelet production by megakaryocytes. Targets: CD38+ long-lived plasma cells and the humoral autoantibody pathway (with potential effects on other CD38+ immune subsets).