Testing REGN7945 with linvoseltamab for relapsed multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and anti-tumor activity of an experimental drug REGN7945 in combination with linvoseltamab in adults with relapsed or refractory multiple myeloma. It aims to determine how well this combination works compared to linvoseltamab alone, focusing on side effects, effectiveness, and duration of benefit. This is the first time REGN7945 will be tested in humans, while linvoseltamab has been previously studied on its own. Participants will be monitored for improvements in their condition and overall tolerability of the treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Royal Prince Alfred Hospital
  Sydney, New South Wales, Australia Recruiting
• Illawarra Cancer Care Centre
  Wollongong, New South Wales, Australia Recruiting
• Pindara Private Hospital
  Benowa, Queensland, Australia Recruiting
• Royal Adelaide Hospital
  Adelaide, South Australia, Australia Recruiting
• Alfred Hospital
  Melbourne, Victoria, Australia Recruiting
• St Vincents Hospital Melbourne
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CT0596 CAR-T in relapsed/refractory multiple myeloma: a phased dose-find and efficacy study

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  Recruiting Phase 1/2 UCARsgen Biotech Limited · Suzhou, Jiangsu and 1 other locations · NCT07760454

• Linvoseltamab with pre-dose Tocilizumab to reduce CRS in adults with relapsed/refractory multiple myeloma

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  Recruiting at 2 sites Phase 1 Genentech, Inc. · Parkville, Victoria and 1 other locations · NCT07558915

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• IL-15–armored CAR-T for relapsed or refractory multiple myeloma and plasma cell leukemia

  This trial will test IL-15–armored CAR-T cell therapy to see if it helps adults with relapsed or refractory multiple myeloma or plasma cell leukemia, including those with persistent or returning MRD.

  Recruiting Phase 2 The First Hospital of Jilin University · Changchun, Jilin · NCT07509086

• IMV102 treatment for relapsed or refractory multiple myeloma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.