eligibility_summary
Adults 18–70 with APS (2006) and triple‑positive aPL (history and at screening: aCL IgG ≥40 GPL, aβ2GPI IgG ≥40 SGU, LA+), vaccinated ≥14 days prior (updated COVID, ≥1 zoster dose, current flu), on warfarin/LMWH if prior thrombosis. Exclude: other systemic autoimmune disease, recent thrombosis/catastrophic APS, infections, abnormal labs, recent IS/biologics/DOACs/CD38 mAbs, major cardiac/organ disease, allergy, pregnancy/breastfeeding/no contraception.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05671757: Phase 1b open-label dose-escalation/expansion in primary antiphospholipid syndrome. Intervention: Daratumumab (DARZALEX), a human IgG1κ anti-CD38 monoclonal antibody, given IV weekly for 8 doses at 4, 8, or 16 mg/kg, expansion at the highest safe dose. Mechanism: depletes CD38+ cells via complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity/phagocytosis, and apoptosis, also inhibits CD38 ectoenzyme (NADase) activity, affecting adenosine signaling. Targets: long-lived plasma cells/plasmablasts producing antiphospholipid antibodies (aCL, anti-β2GPI, LA) and other CD38+ immune cells (e.g., NK/T cells). Pathways: humoral autoimmunity/autoantibody production and the CD38–NAD/adenosine axis.