Recruiting
Phase 1

SAR446523

Sponsor:

Sanofi

Code:

NCT06630806

Conditions

Plasma Cell Myeloma Refractory

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SAR446523

Study Details

Brief 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.

Conditions

Plasma Cell Myeloma Refractory

Study ID

NCT06630806

Start date

Oct 30, 2024

Status verified date

Mar, 2026

Completion date

May 16, 2031

Anticipated

Primary completion date

May 16, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

87 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A (Dose escalation)

Participants will receive SAR446523

experimental: Part B Dose-1 (Dose optimization)

Participants will receive SAR446523 Dose-1

experimental: Part B Dose-2 (Dose optimization)

Participants will receive SAR446523 Dose-2

Interventions

SAR446523

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

Primary outcome measure

  • Incidence of Dose Limiting Toxicities (DLTs)- Dose escalation (Part A) [ Time Frame: Cycle 1 (28 days) ]
  • Overall response rate (ORR) - Dose optimization (Part B) [ Time Frame: 24 months after the Last Participant In (LPI) ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

Mayo Clinic in Arizona - Phoenix- Site Number : 8400005

Recruiting

Phoenix, Arizona, United States, 85054

Mayo Clinic in Florida- Site Number : 8400003

Recruiting

Jacksonville, Florida, United States, 32224

Mayo Clinic in Rochester - Minnesota- Site Number : 8400004

Recruiting

Rochester, Minnesota, United States, 55905

Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001

Recruiting

Hackensack, New Jersey, United States, 07601

Thomas Jefferson University Hospital- Site Number : 8400002

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Investigational Site Number : 1240005

Recruiting

Vancouver, British Columbia, Canada, V5Z 1L3

Investigational Site Number : 1240001

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Investigational Site Number : 1240002

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

Sanofi

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

  • anti-GPRC5D NK cell targeting therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanofi on 2026-03-25.