A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma

Study of an Investigational Study Drug for Relapsed or Refractory Multiple Myeloma

Age
18 years or above
Gender
All
Phase
Phase 1
Participants needed
87
Locations
5
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Study Overview

This is a first-in-human study of SAR446523 conducted in patients with RRMM.

The study consists of two parts:

Dose escalation (Part A): In this part, up to several dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose optimization part.

Dose optimization (Part B): In this part, participants will be randomly assigned in a 1:1 ratio using interactive response technology (IRT) to either one of the chosen dose regimens of SAR446523 (determined from data coming from Part A), to determine the optimal dose as the recommended phase 2 dose (RP2D) of SAR446523.

Study Details

The study will be considered ongoing until the last participant last visit has occurred. Participants will be allowed to continue therapy until disease progression, unacceptable AEs, participant or Investigator's request to discontinue treatment.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Plasma Cell Myeloma Refractory
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Participants with a documented diagnosis of multiple myeloma (MM) with measurable disease.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Dose escalation (Part A)

  • Participants must have received at least 3 prior lines of antimyeloma therapy, and must be either relapsed or refractory to the above therapies, or are intolerant to them.
  • Note: In Part A, prior exposure to anti g-protein-coupled receptor, class c, group 5, member d (GPRC5D) therapy and anti B-cell maturation antigen (BCMA) therapy is allowed.

Dose optimization (Part B)

  • Participants must have received at least 3 prior lines of antimyeloma therapy and be either relapsed or refractory to immunomodulator (IMiD), proteasome inhibitor (PI), anti CD38 monoclonal antibody (mAb), and anti BCMA targeting agent or are intolerant to them.
  • Note: In Part B, prior exposure to antiGPRC5D therapy is not allowed.

Exclusion Criteria:

-Participants are excluded from the study if any of the following criteria apply: Eastern cooperative oncology group performance status (ECOG PS) of 2 or greater.

  • Primary systemic and localized amyloid light chain (AL) amyloidosis, active polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, active plasma cell leukemia. Participants with central nervous system involvement or with clinical signs of meningeal involvement of multiple myeloma.
  • Systemic antimyeloma treatment within 14 days before the first study treatment administration.
  • Prior treatment with natural killer (NK)-cell engaging therapy (such as monoclonal antibody with antibody-dependent cellular cytotoxicity as primary mechanism of action) within 90 days of the first study treatment administration.
  • Inadequate organ and marrow function.
  • Participants with significant concomitant illness.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

The purpose of this research study is to learn about the effects and safety of an investigational study drug in adults with relapsed or refractory multiple myeloma (multiple myeloma that has come back or has not responded to treatment).

Participants will receive an investigational study drug given as an injection under the skin. The study has two parts. In the first part, different dose levels will be tested to help find the highest dose that can be given and a recommended dose range. In the second part, participants will be assigned to receive one of two dose regimens of the investigational study drug to help choose the best dose.

Who can participate:
Adults with multiple myeloma may be able to participate if they:

  • Have a confirmed diagnosis of multiple myeloma with measurable disease
  • Have received at least three prior lines of multiple myeloma treatment
  • Have multiple myeloma that has come back, has not responded to prior treatments, or the treatments caused difficult side effects
  • (For the second part of the study) Have already been treated with an immunomodulator, a proteasome inhibitor, an anti-CD38 antibody treatment, and a treatment that targets BCMA
  • (For the second part of the study) Have not previously received treatment that targets GPRC5D

Updated on 24 Mar 2026. Study ID: NCT06630806

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