This study is researching a drug called REGN17372 used with another drug called linvoseltamab (each individually called "study drug" or "study drugs" when combined) in participants with relapsed (when a tumor comes back) or refractory (when a tumor does not respond to treatment) multiple myeloma. This study is the first time REGN17372 will be given to humans.
The aim of the study is to understand if REGN17372 can be given safely with linvoseltamab, and if so, what dosing regimen should be used for this treatment combination, in comparison with linvoseltamab alone.
The study is looking at:
* What side effects may happen from taking REGN17372 with linvoseltamab * How well REGN17372 and linvoseltamab, or linvoseltamab alone, work in treating multiple myeloma * What is the best dose of REGN17372 when given with linvoseltamab * How much study drug(s) are in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects) * If and how REGN17372 and linvoseltamab affect the overall quality of life, daily activities, symptoms and treatment side effects based on participant own feedback (Phase 2)
Participants with RRMM who have exhausted (or are not a candidate for) all therapeutic options that are expected to provide meaningful clinical benefit and have received at least 3 lines of therapy as defined in the protocol
ECOG performance status score ≤1
Participants must have measurable disease for response assessment as described in the protocol
Adequate hematologic, cardiac, hepatic, and renal function, as described in the protocol
Participants with non-secretory MM, active plasma cell leukemia, known amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome as defined in the protocol
Participants who have known MM brain lesions or CNS involvement
Participants with a history of PML, a neurocognitive condition or CNS movement disorder, or a history of seizure within 12 months prior to entering screening
Prior treatment with GPRC5D-directed immunotherapies (phase 1 and phase 2) and/or prior treatment with a BCMAxCD3 bispecific antibody (phase 2)
Sequential
Linvoseltamab
DrugAdministered per protocol
REGN17372+Linvoseltamab
DrugAdministered per the protocol
Occurrence of Dose Limiting Toxicities (DLTs) from the first dose of REGN17372 in combination with linvoseltamab
Phase 1
Occurrence of Treatment Emergent Adverse Events (TEAEs) associated with REGN17372 in combination with linvoseltamab
Phase 1
Severity of TEAEs associated with REGN17372 in combination with linvoseltamab
Phase 1
Very Good Partial Response (VGPR) or better as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria in patients receiving combination study drugs
Phase 2
Concentrations of REGN17372 in serum
Phase 1 and Phase 2
Concentrations of linvoseltamab in serum
Phase 1 and Phase 2
Occurrence of Anti-Drug Antibodies (ADA) to REGN17372
Phase 1 and Phase 2
Magnitude of ADA to REGN17372
Phase 1 and Phase 2
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