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
Recipient organisationNIHR University College London Hospitals Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodMar 2025 — Aug 2028
In plain English
AI plain-English summary
A new drug combination is being tested for the first time in people with advanced multiple myeloma, a blood cancer that disables the immune system's ability to fight infections. This matters because multiple myeloma often stops responding to existing treatments, leaving patients with few options. The study tests whether adding REGN7945—a bispecific antibody designed to activate immune cells—to the existing drug linvoseltamab can improve outcomes compared to linvoseltamab alone. If the combination proves safe and effective, it could offer a new treatment pathway for patients whose cancer has relapsed or become resistant to current therapies. The study is open-label, meaning both doctors and participants know which treatment is given. It has two parts: the first determines safe dosing, and the second measures side effects and anti-tumour activity. Participants remain on treatment as long as it helps their myeloma or until side effects or disease progression force a stop. This is an early-stage clinical trial. Success would not immediately change clinical practice, but it would justify larger studies and potentially expand the toolkit for treating hard-to-control multiple myeloma.
View original technical description
This is a phase 1 (first in human) study to assess a new treatment for advanced multiple myeloma (MM). Multiple Myeloma is a type of blood cancer that affects plasma cells, which makes antibiotics to fight infections. 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. This is an open-label study. This means that both the study doctor and participant will know which study drug(s) (REGN7945 and linvoseltamab or linvoseltamab alone) they receive. There are 2 parts in the study. The purpose of Part 1 will be to study the side effects and determine the recommended doses of the study drug(s) to be given in Phase 2. The purpose of Part 2 will be to continues to assess the side effects of the study drug(s) and to see how effective the study drug(s) is/are at treating multiple myeloma. The study will include about 186 people worldwide. The length of participation in this study will vary depending upon participants response to treatment with the study drug(s) (either REGN7945 and linvoseltamab or linvoseltamab alone) and what side effects, if any, participants have from the study drug(s). Participants will receive treatment with study drug(s) for as long as the study drug(s) are helping to improve their multiple myeloma or until they experience worsening side effects or their myeloma gets worse. Study procedures will include: Physical examinations, bone marrow biopsy, CT-scans, MRIs, ECGs, Echo, blood and urine tests and completion of questionnaires.
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