eligibility_summary
Eligibility: ECOG ≤1, relapsed/refractory MM after ≥3 prior lines including anti-CD38, IMiD, and PI, prior BCMA therapy allowed, measurable disease, adequate hematologic, hepatic, renal function. Exclude: PCL, AL amyloidosis, Waldenstrom macroglobulinemia, POEMS, recent systemic therapy or SCT, >10 mg prednisone within 72 h, CNS involvement/neurologic disorder, recent live/COVID vaccines, recent other cancer, major CV disease, uncontrolled HIV/HBV/HCV/CMV, allergy to allopurinol and rasburicase.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: REGN7945 plus linvoseltamab (REGN5458) vs linvoseltamab alone. Drug types/mechanisms: Both are bispecific monoclonal antibodies. Linvoseltamab is an anti-BCMA x anti-CD3 T‑cell engager that redirects CD3+ T cells to kill BCMA+ myeloma cells. REGN7945 is an anti-CD38 x anti-CD28 costimulatory bispecific that binds CD38 on myeloma cells and CD28 on T cells to deliver costimulation and amplify T‑cell activation in the presence of CD3 engagement. Targets/pathways: BCMA and CD38 on malignant plasma cells, T cells via CD3 activation and CD28 costimulatory pathways to enhance cytotoxicity.