eligibility_summary
Adults ≥18 with systemic AL amyloidosis, relapsed/refractory or <PR after 2 cycles, prior PI/alkylator/anti‑CD38 and ASCT if eligible, or ineligible/intolerant. Measurable disease (M ≥0.5 g/dL or dFLC ≥50 mg/L), ECOG 0–2, LVEF >35%, organ involvement, controlled HIV/HBV/HCV allowed. Exclude: ASCT‑eligible, treated MM, heart disease, corneal disorder, belantamab allergy, recent surgery/trial drug, contacts, bleeding/infection unstable liver/biliary, uncontrolled illness, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Belantamab mafodotin (GSK2857916), an antibody–drug conjugate (ADC). It is a humanized, afucosylated IgG1 monoclonal antibody against BCMA (TNFRSF17) conjugated to the cytotoxic payload monomethyl auristatin F (MMAF). Mechanism: Binds BCMA on pathogenic plasma cells, is internalized, and releases MMAF to inhibit microtubules and induce apoptosis, the afucosylated antibody can also promote immune effector functions (ADCC/ADCP). Target cells/pathways: BCMA-expressing clonal plasma cells driving AL amyloidosis, targets BCMA signaling on long-lived plasma cells and disrupts microtubule pathways leading to plasma cell death, aiming to reduce circulating amyloidogenic light chains and improve organ involvement. Dosing: 1.0–2.5 mg/kg IV every 4–12 weeks (dose/schedule optimized in Part 1, expanded in Part 2).