eligibility_summary
Eligible: <70, transplant-eligible with adequate organ function, ECOG 0–2, symptomatic, measurable newly diagnosed MM, no prior therapy except palliative radiation or ≤1 month steroids, adequate marrow, hepatic, renal, cardiac. Exclude: concurrent investigational anti-MM or APRIL/TACI/BCMA agents, CNS involvement/PML/seizures/neuro disorders, urgent rapidly progressive disease, non-secretory MM, plasma cell leukemia, AL amyloidosis, WM, POEMS. Others apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Linvoseltamab (REGN5458, Lynozyfic), an IV human bispecific IgG antibody (anti-BCMA × anti-CD3). Mechanism: T‑cell–redirecting immunotherapy that simultaneously binds BCMA (TNFRSF17) on malignant plasma cells and CD3 on T cells, creating an immune synapse to activate cytotoxic T cells and kill BCMA+ myeloma cells (with cytokine release). Targets: BCMA on plasma cells within the APRIL/BAFF–TACI/BCMA axis, CD3 on polyclonal T cells, downstream T‑cell activation/cytolytic pathways (perforin/granzyme). Population: newly diagnosed multiple myeloma, transplant-eligible and -ineligible. Design: Phase 1 dose‑finding and Phase 2 expansion to assess safety, tolerability, PK/ADA, and antitumor activity.