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

Launched by SANOFI · Oct 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SAR446523 for adults with relapsed or refractory multiple myeloma, a type of blood cancer. The study is divided into two parts. In the first part, researchers will test different doses of the medication to find out which dose is the safest and most effective. In the second part, participants will be randomly assigned to receive one of the chosen doses to help determine the best dosage for future studies.

To be eligible for this trial, participants need to have a confirmed diagnosis of multiple myeloma and must have already tried at least three different treatments for their cancer. These treatments should include specific types of therapies, like immunomodulators and proteasome inhibitors. Participants will be closely monitored throughout the study to assess how well the treatment works and what side effects may occur. If you or someone you know is considering participating, it’s important to discuss this option with a healthcare provider to understand the benefits and risks involved.

Gender

ALL

Eligibility 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.