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

Launched by REGENERON PHARMACEUTICALS · Oct 30, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of two experimental drugs, REGN7945 and linvoseltamab, for adults with relapsed or refractory multiple myeloma, a type of blood cancer that has returned after treatment. This is the first time REGN7945 will be tested in humans, while linvoseltamab has been studied before on its own. The goal is to see if combining these two drugs can help improve treatment outcomes compared to using linvoseltamab alone. Researchers will also look at potential side effects, how long the drugs may help, and their impact on patients’ quality of life.

To participate in this trial, individuals must be adults who have had multiple myeloma return after receiving at least three different treatments, including specific types of cancer drugs. They should be in relatively good health, as indicated by a performance status score. However, people with certain other health conditions or recent treatments may not be eligible. Participants in the study can expect regular monitoring for side effects and assessments to see how well the treatment is working. This trial is actively recruiting participants, and those interested should discuss it with their doctor to see if they qualify.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 as described in the protocol
• • 2. Received at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory imide drug (IMiD), and 1 proteasome inhibitor (PI) and have demonstrated disease progression on or after the last therapy, as defined in the protocol. Prior treatment with other BCMA directed immunotherapies, including BCMA CAR-T cells and BCMA antibody-drug conjugates (Phase 1 and 2), and with BCMA x CD3 bispecific antibodies (Phase 1 only), is allowed
• • 3. Participants must have the measurable disease for response assessment as described in the protocol
• • 4. Adequate hematologic, hepatic, and renal function as described in the protocol
• Key Exclusion Criteria:
• • 1. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis (including myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• • 2. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
• • 3. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment
• • 4. Treatment with systemic corticosteroid treatment with more than 10 mg per day of prednisone or steroid equivalent within 72 hours of start of study drug
• • 5. Participants who have known central nervous system (CNS) involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), history of a neurocognitive condition or CNS disorder, or history of seizure within 12 months prior to study enrollment
• • 6. Live or live attenuated vaccination within 28 days before first study drug administration with a vector that has replicative potential
• • 7. Has received a COVID-19 vaccination within 1 week of planned start of study medication as described in the protocol
• • 8. Myelodysplastic syndrome or another malignancy in the past 3 years, except for nonmelanoma skin cancer, in situ carcinoma, thyroid cancer, or low-risk early stage prostate adenocarcinoma, as described in the protocol
• • 9. Significant cardiovascular disease as described in the protocol
• • 10. Uncontrolled infection with HIV, Hep B or Hep C infection, or other uncontrolled infection, such as CMV, as described in the protocol
• • 11. Known hypersensitivity to both allopurinol and rasburicase
• • Note: Other protocol-defined Inclusion/ Exclusion Criteria apply