Investigating SAR446523 for treating relapsed/refractory myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic in Arizona - Phoenix- Site Number : 8400005
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic in Florida- Site Number : 8400003
  Jacksonville, Florida, United States Recruiting
• Mayo Clinic in Rochester - Minnesota- Site Number : 8400004
  Rochester, Minnesota, United States Recruiting
• Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001
  Hackensack, New Jersey, United States Recruiting
• Thomas Jefferson University Hospital- Site Number : 8400002
  Philadelphia, Pennsylvania, United States Recruiting
• Investigational Site Number : 0360001
  Wollongong, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.