eligibility_summary
Patients with primary systemic AL amyloidosis, ECOG <=2, >=1 organ involved, stage 1–3a with measurable disease (dFLC >=50 mg/L), prior exposure to a proteasome inhibitor and an anti-CD38 mAb. Excludes recent substance abuse, allergy to study drugs, non-AL amyloid, symptomatic MM, plasma cell leukemia, Waldenstroms, acute diffuse infiltrative pneumopathy, recent major surgery, transplant needing immunosuppression, acute infections, recent SCT (auto <12 wks, allo <1 yr).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Etentamig (ABBV-383, TNB-383B), an intravenous bispecific T-cell–redirecting antibody (immunotherapy). Mechanism of action: binds BCMA on pathogenic plasma cells and CD3 on T cells, creating an immune synapse that activates cytotoxic T cells to kill BCMA+ plasma cells, thereby reducing production of amyloidogenic light chains. Cells/pathways targeted: BCMA-expressing clonal bone marrow plasma cells, CD3-mediated T-cell activation with perforin/granzyme cytotoxicity, downstream reduction of free light chains and AL amyloid burden. Study: open-label Phase 1b dose escalation/expansion in relapsed/refractory AL amyloidosis.