Actively Recruiting
A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma
Led by Sanofi · Updated on 2026-03-25
87
Participants Needed
19
Research Sites
341 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with a documented diagnosis of multiple myeloma with measurable disease
- Use of contraception by men and women according to local regulations
- For dose escalation (Part A): Must have received at least 3 prior lines of antimyeloma therapy and be relapsed, refractory, or intolerant to them
- For dose optimization (Part B): Must have received at least 3 prior lines of antimyeloma therapy and be relapsed or refractory to immunomodulator, proteasome inhibitor, anti-CD38 monoclonal antibody, and anti-BCMA targeting agent or intolerant to them
You will not qualify if you...
- Eastern Cooperative Oncology Group performance status of 2 or greater
- Primary systemic and localized amyloid light chain amyloidosis, active POEMS syndrome, active plasma cell leukemia
- Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma
- Systemic antimyeloma treatment within 14 days before first study treatment
- Prior treatment with natural killer-cell engaging therapy within 90 days before first study treatment
- Inadequate organ and marrow function
- Significant concomitant illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Mayo Clinic in Arizona - Phoenix- Site Number : 8400005
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic in Florida- Site Number : 8400003
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Mayo Clinic in Rochester - Minnesota- Site Number : 8400004
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001
Hackensack, New Jersey, United States, 07601
Actively Recruiting
5
Thomas Jefferson University Hospital- Site Number : 8400002
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
6
Investigational Site Number : 0360001
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
7
Investigational Site Number : 0360002
Melbourne, Victoria, Australia, 3065
Actively Recruiting
8
Investigational Site Number : 1240005
Vancouver, British Columbia, Canada, V5Z 1L3
Actively Recruiting
9
Investigational Site Number : 1240001
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
10
Investigational Site Number : 1240002
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
11
Investigational Site Number : 2500002
Lille, France, 59037
Actively Recruiting
12
Investigational Site Number : 2500001
Nantes, France, 44093
Actively Recruiting
13
Investigational Site Number : 3760001
Tel Aviv, Malopolskie, Israel, 6423906
Actively Recruiting
14
Investigational Site Number : 3760004
Haifa, Israel, 3109601
Actively Recruiting
15
Investigational Site Number : 3760002
Jerusalem, Israel, 9112001
Actively Recruiting
16
Investigational Site Number : 3800002
Torette, Ancona, Italy, 60020
Actively Recruiting
17
Investigational Site Number : 3800001
Rozzano, Milano, Italy, 20089
Actively Recruiting
18
Investigational Site Number : 7240002
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
19
Investigational Site Number : 7240001
Madrid, Spain, 28040
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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