SAR446523 for Multiple Myeloma

Recruiting at 21 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sanofi

Must not be taking: NK-cell therapy

Disqualifiers: Amyloidosis, POEMS syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

82 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, SAR446523, for individuals with multiple myeloma, a type of blood cancer. The trial aims to determine the right dose for future studies by evaluating different amounts of the treatment in two phases. It seeks participants whose multiple myeloma has not responded well to at least three previous treatments or who cannot tolerate those treatments. Those who have undergone multiple treatments and continue to struggle with this condition might be suitable for the trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop any systemic antimyeloma treatment at least 14 days before starting the study treatment. If you've had NK-cell engaging therapy, you need to wait 90 days before starting the trial.

Is there any evidence suggesting that SAR446523 is likely to be safe for humans?

Research shows that SAR446523 is a new treatment under study for multiple myeloma, a type of blood cancer. No published information exists yet on its safety for humans. This study marks the first time SAR446523 is tested in people, indicating it is in the early stages of research.

In this Phase 1 trial, researchers focus on finding a safe dose and assessing how well patients tolerate the treatment. As it is an early phase, detailed safety information is still being collected.

The treatment has received an orphan drug designation from the FDA, which supports the development of treatments for rare conditions like multiple myeloma. However, this designation does not confirm the treatment's safety or effectiveness.

In summary, while there is interest in SAR446523 as a potential treatment, its safety in humans remains under study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for multiple myeloma, which often include chemotherapy, immunomodulatory drugs, and proteasome inhibitors, SAR446523 offers a novel approach. This treatment is unique because it targets a specific protein on multiple myeloma cells, potentially improving precision and effectiveness. Researchers are excited about SAR446523 as it could provide a more focused attack on cancer cells, possibly leading to better outcomes with fewer side effects. By optimizing the dosage in different parts of the trial, the goal is to maximize the treatment's benefits while minimizing risks.

What evidence suggests that SAR446523 might be an effective treatment for multiple myeloma?

Research has shown that SAR446523 is a promising new treatment for relapsed or refractory multiple myeloma, a type of blood cancer. This trial will explore SAR446523 using different dosing strategies. The drug targets a protein called GPRC5D on cancer cells, employing a monoclonal antibody to help the immune system attack these cells. SAR446523 enhances the ability of natural killer (NK) cells, part of the immune system, to destroy cancer cells. Although studies in humans remain in the early stages, the drug has received orphan drug designation, indicating its potential for treating this serious condition. Early results suggest effectiveness, but further research is needed to confirm its benefits. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with relapsed/refractory multiple myeloma (RRMM) who have tried at least three prior treatments, including specific drugs like immunomodulators, proteasome inhibitors, and anti-CD38 monoclonal antibodies. For part B of the study, patients previously treated with anti-GPRC5D therapies can't participate.

Inclusion Criteria

My previous cancer treatments either didn't work, stopped working, or caused side effects I couldn't tolerate.

I have been diagnosed with multiple myeloma and it can be measured.

My previous cancer treatments either didn't work, stopped working, or I couldn't tolerate them.

Exclusion Criteria

I need some help with daily activities due to my health condition.

Participants with significant concomitant illness

I haven't had any myeloma treatment in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part A)

Participants receive SAR446523 to determine the maximum administered dose, maximum tolerated dose, and recommended dose range

28 days per cycle

Multiple visits per cycle

Dose Optimization (Part B)

Participants are randomly assigned to one of the chosen dose regimens to determine the optimal dose as the recommended phase 2 dose

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months after the last participant in

What Are the Treatments Tested in This Trial?

Interventions

• SAR446523

Trial Overview

The trial tests SAR446523 in RRMM patients. It has two parts: Part A finds the safest high dose by testing up to six levels; Part B uses that info to find the best dose for future studies. Patients are randomly assigned a dosage regimen in Part B.

How Is the Trial Designed?

Group I: Part B Dose-2 (Dose optimization) Experimental Treatment 1 Intervention

Participants will receive SAR446523 Dose-2

Group II: Part B Dose-1 (Dose optimization) Experimental Treatment 1 Intervention

Participants will receive SAR446523 Dose-1

Group III: Part A (Dose escalation) Experimental Treatment 1 Intervention

Participants will receive SAR446523

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

Research into the cellular mechanisms of multiple myeloma has led to new treatment strategies, particularly targeting the role of interleukin-6 in disease progression, which can inhibit myeloma cell growth.

Pamidronate has been effective in reducing skeletal complications in patients with advanced myeloma, highlighting its therapeutic potential in managing the disease's adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the biology and treatment of multiple myeloma. Varterasian, ML.[2019]

Multiple myeloma (MM) is a complex cancer characterized by genetic abnormalities that affect various oncogenic pathways, making it a challenging disease to treat.

Recent advancements in treatment, including immunomodulatory drugs like thalidomide and lenalidomide, and proteasome inhibitors like bortezomib, have improved patient outcomes, but MM remains incurable for most, highlighting the need for ongoing research into new therapeutic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted therapy of multiple myeloma. Dolloff, NG., Talamo, G.[2022]

Multiple myeloma (MM) is characterized by the malignant growth of B-lymphocytes and is associated with various organ damage due to the production of monoclonal components, leading to complications like renal failure and bone disease.

Current treatments for MM include alkylating agents and glucocorticoids, while bisphosphonates have emerged as an effective option for managing bone disease associated with the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple myeloma. Ascari, E., Merlini, G., Riccardi, A.[2005]

Multiple myeloma (MM) presents significant treatment challenges, especially for high-risk patients and those with multi-drug resistant disease, highlighting the need for novel anti-MM agents and personalized treatment strategies.

Identifying specific molecular lesions in different myeloma subtypes and utilizing advanced molecular profiling techniques are crucial for developing effective, tailored therapies and improving patient outcomes in MM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future directions of next-generation novel therapies, combination approaches, and the development of personalized medicine in myeloma. Mitsiades, CS., Davies, FE., Laubach, JP., et al.[2023]

Over 20 years of research and analysis of more than 1000 multiple myeloma genomes have led to a better understanding of the disease's development and potential treatment targets.

The review emphasizes the need to translate genetic and biological insights into clinical practice, suggesting a framework for using targeted therapies and risk stratification to enhance patient management in multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Bench to Bedside: The Evolution of Genomics and Its Implications for the Current and Future Management of Multiple Myeloma. Morgan, GJ., Boyle, EM., Davies, FE.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06630806

NCT06630806 | A Study to Investigate the Safety and ...

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, ...

2.

sanofi.com

sanofi.com/en/media-room/press-releases/2025/2025-07-30-05-00-00-3123737

Press Release: Sanofi's SAR446523, a GPRC5D ...

Sanofi's SAR446523, a GPRC5D monoclonal antibody, earns orphan drug designation in the US for multiple myeloma.

3.

onclive.com

onclive.com/view/sar446523-receives-fda-orphan-drug-designation-for-r-r-myeloma

SAR446523 Receives FDA Orphan Drug Designation for R ...

SAR446523, a GPRC5D-targeted monoclonal antibody, has received orphan drug designation for relapsed or refractory multiple myeloma. The phase 1 ...

4.

cancernetwork.com

cancernetwork.com/view/fda-grants-orphan-drug-designation-to-gprc5d-target-in-multiple-myeloma

FDA Grants Orphan Drug Designation to GPRC5D Target ...

SAR446523 is currently being evaluated in a first-in-human phase 1 trial in patients with pretreated relapsed/refractory multiple myeloma.

5.

library.ehaweb.org

library.ehaweb.org/eha/2025/eha2025-congress/4162057/prashant.kapoor.first-in-human.open-label.phase.1.trial.design.of.sar446523.a.html?f=listing%3D3%2Abrowseby%3D8%2Asortby%3D1%2Amedia%3D1

FIRST-IN-HUMAN, OPEN-LABEL, PHASE 1 TRIAL DESIGN ...

SAR446523, an anti-GPCR5D antibody-dependent cellular cytotoxicity (ADCC)-enhanced monoclonal antibody engages natural killer (NK) cells via ...

6.

multiplemyelomahub.com

multiplemyelomahub.com/medical-information/fda-grants-orphan-drug-designation-to-sar446523-for-the-treatment-of-rrmm

FDA grants orphan drug designation to SAR446523 for the ...

Currently, there are no published safety and efficacy data for SAR446523. The subcutaneous formulation of SAR446523 is being evaluated as part ...

7.

sanofistudies.com

sanofistudies.com/cwout/CW-V9DEXS//ca/en/listing/312982/a-study-to-investigate-16/

A Study to Investigate the Safety and Efficacy

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 ...