eligibility_summary
BMI 18–40, weight ≥40 kg, IgM ≥40 mg/dL. SLE: ACR/EULAR dx, anti‑dsDNA/ANA+, SLEDAI‑2K ≥6, failed ≥2 immunosuppressants. RA: ACR/EULAR 2010, ≥6 mo, RF/anti‑CCP+, ≥3/68 tender and ≥3/66 swollen joints, failed ≥2 therapies. APS: 2023 ACR/EULAR, LA or mod–high aCL/anti‑β2GPI+, AC‑resistant events. Female contraception required. SLE: flare/unstable/organ damage, RA: class IV/adult JRA, APS: acute thrombosis <30d or catastrophic APS <90d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Belantamab (GSK2857914, belantamab mafodotin) — a biological, anti-BCMA antibody–drug conjugate (humanized, afucosylated IgG1 linked to the microtubule inhibitor MMAF). Mechanism: binds BCMA (TNFRSF17) on plasmablasts/long‑lived plasma cells, is internalized, delivers MMAF to induce apoptosis, Fc enhancement drives ADCC/ADCP, depleting antibody‑secreting B‑lineage cells and lowering pathogenic autoantibodies. Target cells/pathways: BCMA+ B‑cell lineage (plasmablasts/plasma cells), BCMA signaling axis in humoral immunity. Population: adults with active SLE, RA, or APS after ≥2 prior immunosuppressants. Design: Phase 1b, single IV dose, dose escalation, endpoints: safety, tolerability, PK, pharmacologic effect. Status: Withdrawn (sponsor decision).