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Investigating SAR446523 for treating relapsed/refractory myeloma

A First-in-human, Open-label, Phase 1 Study to Evaluate the Safety, Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of Subcutaneous SAR446523, an Anti-GPRC5D ADCC-enhanced Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma

Phase 1 Interventional Sanofi · NCT06630806

This study is testing a new treatment called SAR446523 for adults with relapsed or refractory multiple myeloma to see how well it works and find the best dose to use.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment87 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi Industry-sponsored
Locations19 sites (Phoenix, Arizona and 18 other locations)
Trial IDNCT06630806 on ClinicalTrials.gov

What this trial studies

This clinical trial is a first-in-human investigation of SAR446523, an anti-GPRC5D NK cell targeting therapy, in adult patients with relapsed or refractory multiple myeloma (RRMM). The study is divided into two parts: the first part focuses on dose escalation to determine the maximum administered dose and the maximum tolerated dose, while the second part involves dose optimization where participants are randomly assigned to one of the selected dose regimens. The goal is to establish the recommended phase 2 dose for further evaluation. Participants will continue treatment until disease progression or other specified reasons for discontinuation.

Who should consider this trial

Good fit: Ideal candidates are adults with a documented diagnosis of multiple myeloma who have received at least three prior lines of therapy and are either relapsed or refractory to those treatments.

Not a fit: Patients who have not received prior antimyeloma therapies or those with non-measurable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat relapsed or refractory multiple myeloma.

How similar studies have performed: While this approach is novel, similar studies targeting GPRC5D have shown promise in early phases, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Phoenix, Arizona and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Plasma Cell Myeloma Refractoryanti-GPRC5D NK cell targeting therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.