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Relapsed Refractory Multiple Myeloma (RRMM)Phase 1/2NCT07455851

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

A Phase 1/2 study testing Linvoseltamab and REGN17372+Linvoseltamab in people with Relapsed Refractory Multiple Myeloma (RRMM), run by Regeneron Pharmaceuticals at 8 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Linvoseltamab and REGN17372+Linvoseltamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
8 sitesin 2 countries
Study dates
26 Mar 2026to 30 Sep 2033
Phase
Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
  • Note: Other protocol defined inclusion/exclusion criteria apply

Trial locations and contacts

8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

8 sites in 2 countries

Australia6 sites, 6 recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Recruiting

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

    Recruiting

  • Alfred Hospital

    Melbourne, Victoria, 3004

    Recruiting

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

    Recruiting

  • Illawarra Cancer care centre, Wollongong Hospital

    Wollongong, New South Wales, 2500

    Recruiting

Other trials in Australia

Greece2 sites, 2 recruiting

  • Evangelismos General Hospital

    Athens, Attica, 10676

    Recruiting

  • Alexandra Hospital

    Athens, Attica, 11528

    Recruiting

Other trials in Greece

About this study

Official title: 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

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.

Read more

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)
Being tested
Linvoseltamab, REGN17372+Linvoseltamab
Keywords
B-cell maturation antigen (BCMA), Anti-CD3 monoclonal antibodies (mAbs), G-protein-coupled receptor class C group 5 member D (GPRC5D)
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LinvoseltamabDrug

    Also called Lynozyfic™, REGN5458

    Administered per protocol

  • REGN17372+LinvoseltamabDrug

    Administered per the protocol

Study groups in NCT07455851
Study groupRoleWhat they receive
REGN17372 + LinvoseltamabExperimentalPhase 1 Phase 2
Receives: Drug: REGN17372+Linvoseltamab
Linvoseltamab monotherapyActive comparatorPhase 2
Receives: Drug: Linvoseltamab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Phase 1

    Measured: Up to 35 days

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

    Phase 1

    Measured: Up to 5 years

  3. Severity of TEAEs associated with REGN17372 in combination with linvoseltamab

    Phase 1

    Measured: Up to 5 years

  4. 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

    Measured: Within 12 weeks of starting cycle 1

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

    Phase 2

    Measured: Within 12 weeks of starting cycle 1

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

    Phase 2

    Measured: Within 12 weeks of starting cycle 1

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

    Phase 2

    Measured: Within 12 weeks of starting cycle 1

Secondary outcomes (43)

  1. Concentrations of REGN17372 in serum

    Phase 1 and Phase 2

    Measured: Up to 5 years

  2. Concentrations of linvoseltamab in serum

    Phase 1 and Phase 2

    Measured: Up to 5 years

  3. Occurrence of Anti-Drug Antibodies (ADA) to REGN17372

    Phase 1 and Phase 2

    Measured: Up to 5 years

  4. Magnitude of ADA to REGN17372

    Phase 1 and Phase 2

    Measured: Up to 5 years

  5. Incidence of ADA to linvoseltamab

    Phase 1 and Phase 2

    Measured: Up to 5 years

  6. Magnitude of ADA to linvoseltamab

    Phase 1 and Phase 2

    Measured: Up to 5 years

  7. Objective Response Rate (ORR) as assessed by IMWG response criteria as determined by the investigator

    Phase 1 and Phase 2

    Measured: Up to 5 years

  8. Complete response (CR) as assessed by IMWG response criteria as determined by the investigator

    Phase 1 and Phase 2

    Measured: Up to 5 years

  9. VGPR as assessed by IMWG response criteria, as determined by the investigator

    Phase 1 and Phase 2

    Measured: Up to 5 years

  10. Duration of Response (DOR) as assessed by IMWG criteria as determined by the investigator

    Phase 1 and Phase 2

    Measured: Up to 5 years

  11. Progression Free Survival (PFS) as assessed by IMWG criteria as determined by the investigator

    Phase 1 and Phase 2

    Measured: Up to 5 years

  12. Minimal Residual Disease (MRD) negative status (at 10^-5) in participants in CR or better

    Phase 1 and Phase 2

    Measured: Up to 5 years

  13. Overall Survival (OS)

    Phase 1 and Phase 2

    Measured: Up to 5 years

  14. ORR as assessed using the IMWG response criteria as determined by the investigator in patients receiving combination study drugs

    Phase 1

    Measured: Within 12 weeks of starting cycle 1

  15. VGPR assessed using IMWG criteria as determined by the investigator in patients receiving combination study drugs

    Phase 1

    Measured: Within 12 weeks of starting cycle 1

  16. Incidence of TEAEs

    Phase 2

    Measured: Up to 5 years

  17. Severity of TEAEs

    Phase 2

    Measured: Up to 5 years

  18. Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Global Health Status / Quality of Life (GHS/QoL)

    Phase 2 The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much"

    Measured: Up to 5 years

  19. Change from baseline in EORTC QLQ-C30 Physical Functioning (PF)

    Phase 2

    Measured: Up to 5 years

  20. Change from baseline in EORTC QLQ-C30 Role Functioning (RF)

    Phase 2

    Measured: Up to 5 years

  21. Change from baseline in EORTC QLQ-C30 pain

    Phase 2

    Measured: Up to 5 years

  22. Change from baseline in EORTC QLQ-C30 fatigue

    Phase 2

    Measured: Up to 5 years

  23. Time to definitive deterioration in EORTC QLQ-C30 GHS/QoL

    Phase 2

    Measured: Up to 5 years

  24. Time to definitive deterioration in EORTC QLQ-C30 PF

    Phase 2

    Measured: Up to 5 years

  25. Time to definitive deterioration in EORTC QLQ-C30 RF

    Phase 2

    Measured: Up to 5 years

  26. Time to definitive deterioration in EORTC QLQ-C30 pain

    Phase 2

    Measured: Up to 5 years

  27. Time to definitive deterioration in EORTC QLQ-C30 fatigue

    Phase 2

    Measured: Up to 5 years

  28. Time to first improvement in EORTC QLQ-C30 GHS/QoL

    Phase2

    Measured: Up to 5 years

  29. Time to first improvement in EORTC QLQ-C30 PF

    Phase 2

    Measured: Up to 5 years

  30. Time to first improvement in EORTC QLQ-C30 RF

    Phase 2

    Measured: Up to 5 years

  31. Time to first improvement in EORTC QLQ-C30 pain

    Phase 2

    Measured: Up to 5 years

  32. Time to first improvement in EORTC QLQ-C30 fatigue

    Phase 2

    Measured: Up to 5 years

  33. Change from baseline in EORTC QLQ-Multiple Myeloma Module (MY20) Disease Symptoms (DS)

    Phase 2 The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems

    Measured: Up to 5 years

  34. Time to definitive deterioration in EORTC QLQ-MY20 DS

    Phase 2

    Measured: Up to 5 years

  35. Time to first improvement in EORTC QLQ-MY20 DS

    Phase 2

    Measured: Up to 5 years

  36. Change from baseline in EORTC QLQ-MY20 Treatment Side Effects (TSE)

    Phase 2

    Measured: Up to 5 years

  37. Time to definitive deterioration in EORTC QLQ-MY20 TSE

    Phase 2

    Measured: Up to 5 years

  38. Time to first improvement in EORTC QLQ-MY20 TSE

    Phase 2

    Measured: Up to 5 years

  39. Change from baseline in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (EQ-5D-5L VAS)

    Phase 2 The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems

    Measured: Up to 5 years

  40. Time to definitive deterioration in EQ-5D-5L VAS

    Phase 2

    Measured: Up to 5 years

  41. Time to first improvement in EQ-5D-5L VAS

    Phase 2

    Measured: Up to 5 years

  42. Patient-reported overall impact of treatment toxicity measured by Functional Assessment of Cancer Therapy (FACIT) Item GP5

    Phase 2 The FACIT Item GP5 will be used to assess the patient-reported impact of treatment toxicity that uses a single item "I am bothered by side effects of treatment" on a 5-point scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much)

    Measured: Up to 5 years

  43. Patient-reported tolerability as measured by the Patient Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Phase 2 The PRO-CTAE questionnaire assesses side effects and symptoms in cancer clinical trials using a PRO-CTCAE score. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic AEs drawn from the CTCAE

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2026
  2. Study start26 Mar 2026
  3. Primary completion30 Sep 2033 (estimated)
  4. Study completion30 Sep 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Phase 1: non-randomized dose escalation Phase 2: randomized dose expansion
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07455851
Sponsor's protocol ID
R17372-HM-2493
Other IDs
2025-522776-93-00, 2025
Status last verified
Sep 2026
First submitted
2 Mar 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

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