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Clinical Trials in the USA / NCT06630806
Recruiting Phase 1

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

NCT06630806 · tracked via the Priya Life Science USA tracker
Sponsor
Sanofi
Phase
Phase 1
Started
2024-10-30
Last updated
2026-03-25

Condition(s) studied

Plasma Cell Myeloma Refractory

Investigational drug(s) / intervention(s)

SAR446523

SAR446523: Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Mayo Clinic in Arizona - Phoenix- Site Number : 8400005 Phoenix Arizona Recruiting
Mayo Clinic in Florida- Site Number : 8400003 Jacksonville Florida Recruiting
Mayo Clinic in Rochester - Minnesota- Site Number : 8400004 Rochester Minnesota Recruiting
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001 Hackensack New Jersey Recruiting
Thomas Jefferson University Hospital- Site Number : 8400002 Philadelphia Pennsylvania Recruiting
Investigational Site Number : 0360001 Wollongong New South Wales Recruiting
Investigational Site Number : 0360002 Melbourne Victoria Recruiting
Investigational Site Number : 1240005 Vancouver British Columbia Recruiting
Investigational Site Number : 1240001 Montreal Quebec Recruiting
Investigational Site Number : 1240002 Sherbrooke Quebec Recruiting
Investigational Site Number : 2500002 Lille France Recruiting
Investigational Site Number : 2500001 Nantes France Recruiting
Investigational Site Number : 3760001 Tel Aviv Malopolskie Recruiting
Investigational Site Number : 3760004 Haifa Israel Recruiting
Investigational Site Number : 3760002 Jerusalem Israel Recruiting
Investigational Site Number : 3800002 Torette Ancona Recruiting
Investigational Site Number : 3800001 Rozzano Milano Recruiting
Investigational Site Number : 7240002 Barcelona Barcelona [Barcelona] Recruiting
Investigational Site Number : 7240001 Madrid Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06630806 on ClinicalTrials.gov ↗ ← All trials in the USA