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NCT07455851RecruitingPhase 1/2

A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma

A FIH Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN17372, an Anti-GPRC5D 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

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

This study is researching a drug called REGN17372 used with another drug called linvoseltamab (each individually called "study drug" or "study drugs" when combined) in participants with relapsed (when a tumor comes back) or refractory (when a tumor does not respond to treatment) multiple myeloma. This study is the first time REGN17372 will be given to humans. The aim of the study is to understand if REGN17372 can be given safely with linvoseltamab, and if so, what dosing regimen should be used for this treatment combination, in comparison with linvoseltamab alone. The study is looking at: * What side effects may happen from taking REGN17372 with linvoseltamab * How well REGN17372 and linvoseltamab, or linvoseltamab alone, work in treating multiple myeloma * What is the best dose of REGN17372 when given with linvoseltamab * How much study drug(s) are in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects) * If and how REGN17372 and linvoseltamab affect the overall quality of life, daily activities, symptoms and treatment side effects based on participant own feedback (Phase 2)

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
150 (estimated)
First submitted
2 Mar 2026
Start date
26 Mar 2026
Primary completion date
30 Sept 2033
Lead sponsor
Regeneron Pharmaceuticals
NCT number
NCT07455851
EU CT number
2025-522776-93-00

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 150
  • From 26 Mar 2026 to the primary completion date, 30 Sept 2033
  • 9 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants with a history of PML, a neurocognitive condition or CNS movement disorder, or a history of seizure within 12 months prior to entering screening
  • Prior treatment with GPRC5D-directed immunotherapies (phase 1 and phase 2) and/or prior treatment with a BCMAxCD3 bispecific antibody (phase 2)
    • Note: Other protocol defined inclusion/exclusion criteria apply

Other illness

  • Participants with non-secretory MM, active plasma cell leukemia, known amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome as defined in the protocol

Other

  • Participants who have known MM brain lesions or CNS involvement

Who the study is looking for

  • Participants with RRMM who have exhausted (or are not a candidate for) all therapeutic options that are expected to provide meaningful clinical benefit and have received at least 3 lines of therapy as defined in the protocol
  • ECOG performance status score ≤1
  • Participants must have measurable disease for response assessment as described in the protocol
  • Adequate hematologic, cardiac, hepatic, and renal function, as described in the protocol

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital
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AdelaideAustraliaRecruiting
St Vincents Hospital Melbourne
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FitzroyAustraliaRecruiting
South Western Sydney Local Health District - Liverpool Hosptial
Coordinator of this site? Confirm its status
LiverpoolAustraliaRecruiting
Alfred Hospital
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MelbourneAustraliaRecruiting
Peter MacCallum Cancer Centre
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Prince of Wales Hospital
Coordinator of this site? Confirm its status
RandwickAustraliaRecruiting
Illawarra Cancer care centre, Wollongong Hospital
Coordinator of this site? Confirm its status
WollongongAustraliaRecruiting
Evaggelismos Hospital
Coordinator of this site? Confirm its status
AthensGreeceRecruiting
General Hospital of Athens - Alexandra
Coordinator of this site? Confirm its status
AthensGreeceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.