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

NCT07455851 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: R17372-HM-24932025-522776-93-00
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 6

Brief Summary

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)

Conditions

Relapsed Refractory Multiple Myeloma (RRMM)

Keywords

B-cell maturation antigen (BCMA); Anti-CD3 monoclonal antibodies (mAbs); G-protein-coupled receptor class C group 5 member D (GPRC5D)

Outcome Measures

Primary Outcomes (7)

• Occurrence of Dose Limiting Toxicities (DLTs) from the first dose of REGN17372 in combination with linvoseltamab

  Phase 1

  Up to 35 days

• Occurrence of Treatment Emergent Adverse Events (TEAEs) associated with REGN17372 in combination with linvoseltamab

  Phase 1

  Up to 5 years

• Severity of TEAEs associated with REGN17372 in combination with linvoseltamab

  Phase 1

  Up to 5 years

• 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 study drugs

  Phase 2

  Within 12 weeks of starting cycle 1

• VGPR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy

  Phase 2

  Within 12 weeks of starting cycle 1

• Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination study drugs

  Phase 2

  Within 12 weeks of starting cycle 1

• PR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy

  Phase 2

  Within 12 weeks of starting cycle 1

Secondary Outcomes (43)

• Concentrations of REGN17372 in serum

  Up to 5 years

• Concentrations of linvoseltamab in serum

  Up to 5 years

• Occurrence of Anti-Drug Antibodies (ADA) to REGN17372

  Up to 5 years

• Magnitude of ADA to REGN17372

  Up to 5 years

• Incidence of ADA to linvoseltamab

  Up to 5 years

Study Arms (2)

REGN17372 + Linvoseltamab

EXPERIMENTAL

Phase 1 Phase 2

Drug: REGN17372+Linvoseltamab

Linvoseltamab monotherapy

ACTIVE COMPARATOR

Phase 2

Drug: Linvoseltamab

Interventions

Linvoseltamab DRUG

Administered per protocol

Also known as: Lynozyfic™, REGN5458

Linvoseltamab monotherapy

REGN17372+Linvoseltamab DRUG

Administered per the protocol

REGN17372 + Linvoseltamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants with non-secretory MM, active plasma cell leukemia, known amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome as defined in the protocol
• Participants who have known MM brain lesions or CNS involvement
• 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)

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (6)

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

RECRUITING

Illawarra Cancer care centre, Wollongong Hospital

Wollongong, New South Wales, 2500, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Evangelismos General Hospital

Athens, Attica, 10676, Greece

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1: non-randomized dose escalation Phase 2: randomized dose expansion

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): September 30, 2033
• Study Completion (Estimated): September 30, 2033
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

AU (5); GR (1)