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RecruitingLast updated: 7 August 2026

Testing a new combination treatment (REGN17372 + linvoseltamab) in people with relapsed or refractory multiple myeloma (R/R MM)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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Clinical summary

Summary

This study is testing a new drug called REGN17372 given together with another drug called linvoseltamab in people with relapsed or refractory multiple myeloma (when the cancer has come back or is no longer responding to treatment).

This is the first time REGN17372 is being given to people.

The aim is to find out:

  • if REGN17372 can be safely given with linvoseltamab
  • what the best dose of REGN17372 is when used in combination
  • how well the combination works compared with linvoseltamab alone
The study is also looking at:
  • side effects of the treatment
  • how well the treatments control the cancer
  • how the drugs behave in the body (pharmacokinetics)
  • whether the body develops antibodies to the drugs
  • quality of life and symptoms (in Phase 2)
Study design
This study has two phases:
 
Phase 1
  • All participants receive the combination treatment (REGN17372 + linvoseltamab)
  • The aim is to test safety and find the best dose of REGN17372
Phase 2
  • Participants are treated in one of two groups:
    • Combination group: REGN17372 + linvoseltamab
    • Comparator group: linvoseltamab alone
  • The aim is to further assess safety and compare how well the combination works versus the single drug

Conditions

This trial is treating people with relapsed or refractory multiple myeloma who have had at least 3 previous lines of treatment

Eligibility

Inclusion

  1. 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
  2. ECOG performance status score ≤1
  3. Participants must have measurable disease for response assessment as described in the protocol
  4. Adequate hematologic, cardiac, hepatic, and renal function, as described in the protocol

Exclusion

  1. Participants with non-secretory MM, active plasma cell leukemia, known amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome as defined in the protocol
  2. Participants who have known MM brain lesions or CNS involvement
  3. 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
  4. 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

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Regeneron Pharmaceuticals

Scientific 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

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