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RECRUITING
NCT06669247
PHASE1/PHASE2

A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is researching an experimental drug called REGN7945 in combination with another experimental drug called linvoseltamab, (also known as REGN5458) (each individually called a "study drug" or "study drugs" when combined). This study is the first time REGN7945 will be tested in humans. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after several other therapies had failed. The aim of the study is to see how safe, tolerable, and effective REGN7945 is when given in combination with linvoseltamab, compared with linvoseltamab alone. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How many people treated with REGN7945 and linvoseltamab compared to linvoseltamab alone have improvement of their multiple myeloma and by how much * How long people benefit from receiving REGN7945 in combination with linvoseltamab compared with linvoseltamab alone * How much study drug(s) is in the blood at different times * Whether the body makes antibodies against the study drugs(s) (which could make the study drug(s) less effective or could lead to side effects) * If there is any change in pain and cancer-related symptoms, how well people are able to function, and their quality of life when taking the study drug(s)

Official title: A First-in-Human (FIH) Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN7945, an Anti-CD38 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

186

Start Date

2024-12-11

Completion Date

2035-11-01

Last Updated

2025-07-08

Healthy Volunteers

No

Interventions

DRUG

Linvoseltamab

Administered per protocol

DRUG

REGN7945+Linvoseltamab

Administered per protocol

Locations (7)

Illawarra Cancer Care Centre

Wollongong, New South Wales, Australia

Pindara Private Hospital

Benowa, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

St Vincent's Hospital - Melbourne

Fitzroy, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

University College London Hospitals

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom