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New shot aims to control Hard-to-Treat bone marrow cancer

NCT ID NCT06630806

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new antibody drug (SAR446523) given as a shot under the skin for people with multiple myeloma that has returned or stopped responding to at least three prior treatments. The study has two parts: first, finding the safest and most effective dose, then comparing two dose schedules. The goal is to control the cancer, not cure it, and researchers will monitor side effects and tumor response.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 87 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Plasma cell myeloma refractory

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    19 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

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

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Investigational Site Number : 0360001

    RECRUITING

    Wollongong, New South Wales, 2500, Australia

  • Investigational Site Number : 0360002

    RECRUITING

    Melbourne, Victoria, 3065, Australia

  • Investigational Site Number : 1240001

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Investigational Site Number : 1240002

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Investigational Site Number : 1240005

    RECRUITING

    Vancouver, British Columbia, V5Z 1L3, Canada

  • Investigational Site Number : 2500001

    RECRUITING

    Nantes, 44093, France

  • Investigational Site Number : 2500002

    RECRUITING

    Lille, 59037, France

  • Investigational Site Number : 3760001

    RECRUITING

    Tel Aviv, Malopolskie, 6423906, Israel

  • Investigational Site Number : 3760002

    RECRUITING

    Jerusalem, 9112001, Israel

  • Investigational Site Number : 3760004

    RECRUITING

    Haifa, 3109601, Israel

  • Investigational Site Number : 3800001

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number : 3800002

    RECRUITING

    Torette, Ancona, 60020, Italy

  • Investigational Site Number : 7240001

    RECRUITING

    Madrid, 28040, Spain

  • Investigational Site Number : 7240002

    RECRUITING

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Mayo Clinic in Arizona - Phoenix- Site Number : 8400005

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Florida- Site Number : 8400003

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic in Rochester - Minnesota- Site Number : 8400004

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Thomas Jefferson University Hospital- Site Number : 8400002

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.