eligibility_summary
Eligibility: Age ≥6, ITP ≥3 mo, platelets <30×10^9/L, failed steroids + ≥1 second-line (rituximab/TPO-RA), ≥2 wks since emergency ITP therapy, normal hepatic/renal, ECOG/NYHA ≤2, stable maintenance meds, off immunosuppressants ≥4 wks, rituximab >3 mo, splenectomy >6 mo. Exclude: daratumumab allergy/refractory (<6-mo response), HIV+ or active HBV/HCV/CMV/EBV/syphilis, severe bleeding, cardiac/HTN/thrombotic dz, prior allo/organ transplant, unresolved toxicity, on antiplatelets, pregnant/lactating.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Intravenous anti‑CD38 monoclonal antibody (immunotherapy), 16 mg/kg weekly for 8 doses. Mechanism of action: Binds CD38 on plasma cells, especially long‑lived autoreactive plasma cells/plasmablasts, leading to their depletion via Fc‑mediated effector functions (e.g., ADCC/CDC/ADCP) and apoptosis, thereby reducing pathogenic anti‑platelet autoantibodies. Cells/pathways targeted: CD38+ plasma cells (including splenic LLPC) that drive humoral autoimmunity in ITP, downstream effect is reduced antibody‑mediated platelet destruction and potential recovery of megakaryocyte‑driven platelet production. Population: pediatric refractory/relapsed ITP.