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Clinical Trials in the UK / NCT06669247
Recruiting Phase 1/2

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

NCT06669247 · tracked via the Priya Life Science UK tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 1/2
Started
2024-12-11
Last updated
2026-08-05

Condition(s) studied

Relapsed/Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

Linvoseltamab →REGN7945+Linvoseltamab →

Linvoseltamab: Administered per protocol

REGN7945+Linvoseltamab: Administered per protocol

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of dose limiting toxicities (DLTs) from the first dose of REGN7945 in combination with linvoseltamab — Up to 21 days
    Phase 1
  • Incidence of treatment emergent adverse events (TEAEs) during the treatment period with REGN7945 in combination with linvoseltamab — Up to 5 years
    Phase 1
  • Severity of TEAEs during the treatment period with REGN7945 in combination with linvoseltamab — Up to 5 years
    Phase 1
  • Very Good Partial Response (VGPR) or better as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria in patients receiving combination therapy — Within 12 weeks of starting cycle 1
    Phase 2
  • VGPR or better as determined by the investigator using the IMWG response criteria in patients receiving linvoseltamab monotherapy — Within 12 weeks of starting cycle 1
    Phase 2
  • Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination therapy — Within 12 weeks of starting cycle 1
    Phase 2
  • PR or better as determined by the investigator using the IMWG response criteria in patients receiving linvoseltamab monotherapy — Within 12 weeks of starting cycle 1
    Phase 2

Trial sites (9)

FacilityCityRegionStatus
Royal Prince Alfred Hospital Sydney New South Wales Recruiting
Illawarra Cancer Care Centre Wollongong New South Wales Recruiting
Pindara Private Hospital Benowa Queensland Recruiting
Royal Adelaide Hospital Adelaide South Australia Recruiting
Alfred Hospital Melbourne Victoria Recruiting
St Vincents Hospital Melbourne Melbourne Victoria Recruiting
University College London Hospitals London United Kingdom Recruiting
St Thomas Hospital London United Kingdom Recruiting
The Christie NHS Foundation Trust Manchester United Kingdom Recruiting

More Regeneron Pharmaceuticals trials in the UK

A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis) Recruiting
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease Recruiting
A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma Recruiting
Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma Active, not recruiting
A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) in Pediatric, Adolescent and Adult Participants With Hemophilia B Recruiting

Other trials for the same condition

A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma Active, not recruiting
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma Recruiting
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma Recruiting
A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06669247 on ClinicalTrials.gov ↗ ← All trials in the UK