Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07455851

A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult 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.

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)

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Relapsed Refractory Multiple Myeloma (RRMM) Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Prince of Wales Hospital, Randwick, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Treatment and study plan

Linvoseltamab

Drug

Administered per protocol

Other names: Lynozyfic™, REGN5458

REGN17372+Linvoseltamab

Drug

Administered per the protocol

Primary outcomes

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

    Time frame: Up to 35 days

    Phase 1

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

    Time frame: Up to 5 years

    Phase 1

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

    Time frame: Up to 5 years

    Phase 1

  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

    Time frame: Within 12 weeks of starting cycle 1

    Phase 2

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

    Time frame: Within 12 weeks of starting cycle 1

    Phase 2

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

    Time frame: Within 12 weeks of starting cycle 1

    Phase 2

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

    Time frame: Within 12 weeks of starting cycle 1

    Phase 2

Secondary outcomes

  1. Concentrations of REGN17372 in serum

    Time frame: Up to 5 years

    Phase 1 and Phase 2

  2. Concentrations of linvoseltamab in serum

    Time frame: Up to 5 years

    Phase 1 and Phase 2

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

    Time frame: Up to 5 years

    Phase 1 and Phase 2

  4. Magnitude of ADA to REGN17372

    Time frame: Up to 5 years

    Phase 1 and Phase 2

  5. Incidence of ADA to linvoseltamab

    Time frame: Up to 5 years

    Phase 1 and Phase 2

  6. Magnitude of ADA to linvoseltamab

    Time frame: Up to 5 years

    Phase 1 and Phase 2

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

    Time frame: Up to 5 years

    Phase 1 and Phase 2

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

    Time frame: Up to 5 years

    Phase 1 and Phase 2

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

    Time frame: Up to 5 years

    Phase 1 and Phase 2

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

    Time frame: Up to 5 years

    Phase 1 and Phase 2

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

    Time frame: Up to 5 years

    Phase 1 and Phase 2

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

    Time frame: Up to 5 years

    Phase 1 and Phase 2

  13. Overall Survival (OS)

    Time frame: Up to 5 years

    Phase 1 and Phase 2

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

    Time frame: Within 12 weeks of starting cycle 1

    Phase 1

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

    Time frame: Within 12 weeks of starting cycle 1

    Phase 1

  16. Incidence of TEAEs

    Time frame: Up to 5 years

    Phase 2

  17. Severity of TEAEs

    Time frame: Up to 5 years

    Phase 2

  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)

    Time frame: Up to 5 years

    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"

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase 2

  21. Change from baseline in EORTC QLQ-C30 pain

    Time frame: Up to 5 years

    Phase 2

  22. Change from baseline in EORTC QLQ-C30 fatigue

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase2

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    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

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    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

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 5 years

    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)

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

    Time frame: Up to 5 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Mar 6, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.