A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma

Официальное название

A FIH Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN17372, an Anti-GPRC5D x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma

Обзор

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)

Вмешательства

• Препарат Linvoseltamab
  Administered per protocol
• Препарат REGN17372+Linvoseltamab
  Administered per the protocol

Первичные конечные точки

• Occurrence of Dose Limiting Toxicities (DLTs) from the first dose of REGN17372 in combination with linvoseltamab [Срок оценки: Up to 35 days]
• Occurrence of Treatment Emergent Adverse Events (TEAEs) associated with REGN17372 in combination with linvoseltamab [Срок оценки: Up to 5 years]
• Severity of TEAEs associated with REGN17372 in combination with linvoseltamab [Срок оценки: Up to 5 years]
• 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 [Срок оценки: Within 12 weeks of starting cycle 1]
• VGPR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy [Срок оценки: Within 12 weeks of starting cycle 1]
• Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination study drugs [Срок оценки: Within 12 weeks of starting cycle 1]
• PR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy [Срок оценки: Within 12 weeks of starting cycle 1]

Вторичные конечные точки (12)

• Concentrations of REGN17372 in serum [Срок оценки: Up to 5 years]
• Concentrations of linvoseltamab in serum [Срок оценки: Up to 5 years]
• Occurrence of Anti-Drug Antibodies (ADA) to REGN17372 [Срок оценки: Up to 5 years]
• Magnitude of ADA to REGN17372 [Срок оценки: Up to 5 years]
• Incidence of ADA to linvoseltamab [Срок оценки: Up to 5 years]
• Magnitude of ADA to linvoseltamab [Срок оценки: Up to 5 years]
• Objective Response Rate (ORR) as assessed by IMWG response criteria as determined by the investigator [Срок оценки: Up to 5 years]
• Complete response (CR) as assessed by IMWG response criteria as determined by the investigator [Срок оценки: Up to 5 years]
• VGPR as assessed by IMWG response criteria, as determined by the investigator [Срок оценки: Up to 5 years]
• Duration of Response (DOR) as assessed by IMWG criteria as determined by the investigator [Срок оценки: Up to 5 years]
• Progression Free Survival (PFS) as assessed by IMWG criteria as determined by the investigator [Срок оценки: Up to 5 years]
• Minimal Residual Disease (MRD) negative status (at 10^-5) in participants in CR or better [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Note: Other protocol defined inclusion/exclusion criteria apply

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 5 центров

• Prince of Wales Hospital — Randwick
• Illawarra Cancer care centre, Wollongong Hospital — Wollongong
• Royal Adelaide Hospital — Adelaide
• Peter MacCallum Cancer Centre — Melbourne
• Alfred Hospital — Melbourne

Греция · 1 центр

• Evangelismos General Hospital — Athens

Идентификаторы

NCT: NCT07455851 · R17372-HM-2493 · 2025-522776-93-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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