eligibility_summary
Eligibility: Adults with relapsed/refractory AL amyloidosis after ≥1 prior line (incl. Dara+CyBorD) with progression (dFLC>20 mg/L), Phase 2 requires measurable FLC/M-spike. ECOG ≤2, adequate counts, liver, CrCl ≥30, cardiac stage I–IIIa, controlled HBV/HCV. Belantamab allowed only if stopped for intolerance (not refractory/immediate prior). Exclude prior BCMA bispecific/CAR-T, active MM (CRAB), stage IIIB, pregnancy/HIV/autoimmune, major cardiac disease/QTc>550, recent surgery, planned/eligible transplant, unresolved ≥G2 AEs, other cancers (except low-risk).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Elranatamab (Elrexfio) — a subcutaneous, humanized bispecific monoclonal antibody (T‑cell–redirecting immunotherapy). Mechanism: Simultaneously binds BCMA (TNFRSF17) on clonal plasma cells and CD3 on T cells, creating an immune synapse that activates TCR/CD3 signaling, drives cytokine release, and mediates perforin/granzyme cytotoxic killing of BCMA+ plasma cells, aiming to lower amyloidogenic light-chain production. Targets: BCMA-expressing malignant plasma cells, CD3+ T lymphocytes, BCMA and TCR/CD3 signaling pathways.