eligibility_summary
Eligible: HR-MGUS or non-high-risk SMM, ECOG ≤1, adequate hematologic/hepatic function, GFR ≥30 mL/min/1.73 m2 (MDRD). Exclude: high-risk SMM, myeloma-defining events, AL amyloidosis, WM, solitary plasmacytoma, or symptomatic MM, significant cardiac/vascular disease within 3 months, infection needing hospitalization or IV therapy within 28 days of first linvoseltamab, uncontrolled HIV/HBV/HCV or other uncontrolled infection. Other criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06140524 tests linvoseltamab (REGN5458), a bispecific T‑cell–engaging monoclonal antibody immunotherapy targeting BCMA×CD3, in adults with high-risk MGUS or non–high-risk smoldering myeloma. Mechanism: linvoseltamab binds BCMA (TNFRSF17) on abnormal plasma cells and CD3 on T cells, creating an immune synapse that activates T cells to release perforin/granzymes and cytokines, leading to targeted lysis of BCMA+ plasma cells and reduction of M‑protein, aiming to intercept progression to multiple myeloma. Cells/pathways targeted: clonal BCMA-expressing plasma cells, effector CD3+ T cells, BCMA survival signaling axis and TCR/CD3 activation pathways. Single investigational agent with step-up and multiple dosing regimens, safety, PK, and anti-drug antibodies assessed.