eligibility_summary
Include: Adults ≥18 with MM, ≥3 prior lines (IMiD, PI, anti‑CD38) with progression, ASCT >100 d allowed, ECOG 0–2, measurable disease, adequate organs. Exclude: AL amyloidosis/POEMS/plasma cell leukemia, CNS MM, ocular disease, unstable liver/CV disease, active infection (HIV/HBV/HCV unless controlled), prior allo‑SCT, recent CAR‑T or anti‑myeloma therapy, vaccine limits. Part1: belantamab‑refractory excluded. Part2: no prior belantamab, anti‑BCMA needs 6‑mo washout.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1/2, open-label study in relapsed/refractory multiple myeloma (≥3 prior lines). Interventions: 1) Belantamab (GSK2857914) monotherapy—an afucosylated humanized IgG1 monoclonal antibody (mAb) targeting BCMA (TNFRSF17). 2) Combination of belantamab plus belantamab mafodotin (GSK2857916), delivered as separate drugs. 3) Optional post-progression single-agent belantamab mafodotin. Mechanisms: Belantamab binds BCMA on malignant plasma cells, activating immune effector functions (ADCC via NK cells, ADCP via macrophages) through FcγR engagement and may induce apoptosis. Belantamab mafodotin is an anti-BCMA antibody–drug conjugate (ADC) carrying MMAF, after BCMA-mediated internalization, MMAF disrupts microtubules causing cell death, it also retains Fc-mediated ADCC/ADCP. Targets: BCMA+ plasma cells, pathways include BCMA signaling, Fc-mediated cytotoxicity/phagocytosis, and microtubule inhibition.