eligibility_summary
Eligible: confirmed AL amyloidosis, measurable disease by dFLC, ≥1 prior therapy and in need of further treatment, NT‑proBNP ≤8500 ng/L, adequate hepatic/hematologic/renal/cardiac function, ECOG 0–2. Exclude: non‑AL amyloidosis, >60% marrow plasmacytosis, lytic lesions or extramedullary plasmacytoma, MI within 6 months, active infection requiring hospitalization or IV therapy within 28 days. Other criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Linvoseltamab (REGN5458, Lynozyfic), an intravenous bispecific monoclonal antibody (T‑cell engager) that binds BCMA on plasma cells and CD3 on T cells. Mechanism: brings CD3+ T cells into contact with BCMA+ clonal plasma cells to activate T‑cell cytotoxicity and deplete the plasma cells producing pathogenic light chains, aiming to reduce dFLC and improve cardiac/renal organ involvement. Targets/pathways: BCMA-expressing plasma cells, CD3-mediated T‑cell activation/TCR signaling leading to cell-mediated cytotoxicity and decreased amyloidogenic light-chain production. Trial: Phase 1/2 dose escalation then randomized dose expansion assessing safety, dosing, PK/PD, immunogenicity, and hematologic/organ responses in relapsed/refractory systemic AL amyloidosis.