eligibility_summary
Include: High-risk smoldering multiple myeloma diagnosed ≤5 years, ECOG 0–1, adequate hematologic/hepatic function, eGFR ≥30 mL/min/1.73 m². Exclude: any SLiM-CRAB myeloma-defining event, AL amyloidosis, Waldenström macroglobulinemia, soft-tissue plasmacytoma, or symptomatic MM, significant cardiac/vascular disease within 3 months, serious infection needing hospital/IV within 28 days, uncontrolled HIV/HBV/HCV or other infections, severe allergy to similar agents. Other criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Linvoseltamab (REGN5458), an intravenous bispecific T‑cell–engaging antibody. Mechanism of action: simultaneously binds BCMA (TNFRSF17) on plasma cells and CD3 on T cells, forming an immune synapse that activates TCR/CD3 signaling and drives perforin/granzyme‑mediated cytotoxicity against BCMA+ cells, can also deplete normal BCMA+ plasma cells. Cells/pathways targeted: • Malignant clonal plasma cells in high‑risk smoldering multiple myeloma via BCMA, a TNF receptor superfamily member critical for plasma‑cell survival (BAFF/APRIL–BCMA axis). • CD3+ T lymphocytes to redirect cytotoxic activity. Trial intent: assess safety, tolerability, pharmacokinetics/anti‑drug antibodies, and anti‑plasma cell activity to prevent progression to overt multiple myeloma (Phase 2, step‑up dosing run‑in then monotherapy expansion).