RecruitingPhase 1Phase 2NCT06669247

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

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


Sponsor

Regeneron Pharmaceuticals

Enrollment

186 participants

Start Date

Dec 11, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug combination — REGN7945 plus linvoseltamab (two bispecific antibodies that help the immune system attack cancer) — for people with multiple myeloma (a blood cancer) whose disease has come back or stopped responding after three or more prior treatments. **You may be eligible if...** - You are an adult with relapsed/refractory multiple myeloma - You have received at least 3 prior treatment lines including an anti-CD38 antibody, an immunomodulatory drug (like lenalidomide), and a proteasome inhibitor - Your disease is still measurable and has progressed on your last treatment - You have adequate blood counts and organ function **You may NOT be eligible if...** - You have plasma cell leukemia, amyloidosis, or POEMS syndrome - You received cancer therapy within 28 days or 5 half-lives before starting - You had a stem cell transplant recently (allogeneic within 6 months, autologous within 12 weeks) - You are on high-dose steroids within 72 hours of starting - You have known brain or nervous system involvement with myeloma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLinvoseltamab

Administered per protocol

DRUGREGN7945+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

Alfred Hospital

Melbourne, Victoria, Australia

St Vincents Hospital Melbourne

Melbourne, Victoria, Australia

University College London Hospitals

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06669247


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