eligibility_summary
Adults >=18 with APS, refractory/relapsed after steroids and >=1 second-line (e.g., rituximab/CSA/CTX) or unable to use them, platelets <30 x10^9/L, normal liver/renal, ECOG <=2, NYHA <=2, consent. Exclude: prior anti-CD38, uncontrolled major organ disease/cancer, HIV+, active HBV/HCV/CMV/EBV/syphilis, severe bleeding, cardiac disease/arrhythmia/uncontrolled HTN, thrombosis, allogeneic/organ transplant, psych disorder, unresolved toxicity, sepsis, pregnant/lactating.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05983952 tests an anti-CD38 monoclonal antibody (daratumumab-class, immunotherapy) in APS with severe secondary thrombocytopenia refractory to steroids and ≥1 second-line therapy. Mechanism: binds CD38 on antibody-secreting plasma cells and plasmablasts, inducing cell depletion (via ADCC/CDC/apoptosis) and immune modulation, thereby lowering antiphospholipid antibody titers (anti-β2GPI, aCL, lupus anticoagulant). Targeted cells/pathways: CD38+ long‑lived plasma cells driving humoral autoimmunity, downstream reduction of aPL-mediated procoagulant signaling (β2GPI-dependent pathways), platelet activation/consumption and complement activation, aiming to improve platelet counts and reduce thrombotic risk. Intervention: IV 16 mg/kg weekly for 8 weeks, single-arm Phase 2.