Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase1/Phase2

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

Sponsor: Regeneron Pharmaceuticals

NCT ID: NCT06669247

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Linvoseltamab (drug), REGN7945+Linvoseltamab (drug)
How long the study runs
Study runs about 131 months (dates as stated)
About the drug or intervention
Linvoseltamab — drug: Administered per protocol · REGN7945+Linvoseltamab — drug: Administered per protocol
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at the safety and anti-tumour activity of a new drug called REGN7945 when given together with linvoseltamab in adults with relapsed or refractory multiple myeloma. Relapsed means the cancer has come back, and refractory means it has not responded to treatment. The study is funded by Regeneron Pharmaceuticals.

Who can take part

  • You can carry out everyday activities fairly well (performance status of 1 or less on a scale used by doctors)
  • You have had at least 3 previous courses of treatment, including an anti-CD38 antibody drug, an immunomodulatory drug (IMiD), and a proteasome inhibitor, and your disease got worse during or after your last treatment
  • Previous treatment aimed at BCMA (a protein on myeloma cells), including BCMA CAR-T cells and BCMA antibody-drug conjugates, is allowed (for phases 1 and 2), and BCMA x CD3 bispecific antibodies are allowed in phase 1 only
  • Your disease can be measured to check how well treatment works
  • Your blood, liver and kidney function are good enough, as set out in the trial rules

Who may not be able to

  • You have plasma cell leukaemia, light-chain amyloidosis, Waldenström macroglobulinaemia, or POEMS syndrome
  • You have had any systemic anti-cancer treatment within 5 half-lives or 28 days of the first study drug dose, whichever is shorter
  • You had a donor (allogeneic) stem cell transplant within 6 months, or your own (autologous) stem cell transplant within 12 weeks of starting study treatment
  • You have taken more than 10 mg per day of steroid (such as prednisone) within 72 hours of starting the study drug
  • Your myeloma has spread to the brain or spinal cord, or you have or may have PML (a rare brain infection), a memory or brain condition, or a seizure within the past 12 months
  • You have had a live or live weakened vaccine within 28 days of the first study dose, or a COVID-19 vaccine within 1 week of starting study treatment
  • You have had myelodysplastic syndrome or another cancer in the past 3 years, apart from non-melanoma skin cancer, carcinoma in situ, thyroid cancer, or low-risk early stage prostate cancer
  • You have significant heart disease as described in the trial rules
  • You have an uncontrolled infection such as HIV, hepatitis B, hepatitis C or CMV
  • You are allergic to both allopurinol and rasburicase

What taking part involves

  • • Taking the study drug REGN7945 together with another drug called linvoseltamab
  • • Neither drug nor how they are given (for example by drip or injection) is described — ask the trial team

Time commitment: How long the study lasts, how often you visit the clinic, and what tests or procedures are involved are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
186
Started
2024-12-11
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for relapsed/refractory multiple myeloma
  • • Phase1/Phase2 - 186 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with relapsed/refractory multiple myeloma

Where?

  • • London - University College London Hospitals
  • • London - St Thomas Hospital
  • • Manchester - The Christie NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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)

Relapsed/Refractory Multiple Myeloma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD38CD3

Treatment history

Treatments you must have had:

  • ✓ other BCMA directed immunotherapies
  • ✓ the measurable disease for response assessment as described in the protocol

What the study is looking for

  • ✓activity scale (ECOG) performance status ≤1 as described in the protocol
  • ✓Participants must have the cancer that can be measured on scans for response assessment as described in the protocol
  • ✓Adequate blood, liver, and kidney function as described in the protocol

Who cannot take part

  • ✗Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of...
  • ✗History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12...
  • ✗Treatment with systemic corticosteroid treatment with more than 10 mg per day of prednisone or steroid equivalent...
  • ✗Live or live attenuated vaccination within 28 days before first the study treatment administration with a vector that has...
  • ✗Has received a COVID-19 vaccination within 1 week of planned start of study medication as described in the protocol
See the full 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

Where Is This Study? (3 UK sites)

University College London Hospitals

London NW1 2PG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

St Thomas Hospital

London SE1 7EH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

The Christie NHS Foundation Trust

Manchester M20 4BQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

How to Get in Touch

Clinical Trials Administrator

Sponsor contact

CONTACT

844-734-6643 clinicaltrials@regeneron.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08