Plasma Cell Myeloma RefractoryPhase 1NCT06630806
A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma
A Phase 1 study testing SAR446523 in people with Plasma Cell Myeloma Refractory, run by Sanofi at 19 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Myeloma Refractory
- What is being tested?
- SAR446523
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 19 sitesin 7 countries
- Study dates
- 30 Oct 2024to 16 May 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -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.
Trial locations and contacts
19 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
19 sites in 7 countries
United States5 sites, 5 recruiting
- Recruiting
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001
Hackensack, New Jersey, 07601
- Recruiting
Mayo Clinic in Florida- Site Number : 8400003
Jacksonville, Florida, 32224
- Recruiting
Thomas Jefferson University Hospital- Site Number : 8400002
Philadelphia, Pennsylvania, 19107
- Recruiting
Mayo Clinic in Arizona - Phoenix- Site Number : 8400005
Phoenix, Arizona, 85054
- Recruiting
Mayo Clinic in Rochester - Minnesota- Site Number : 8400004
Rochester, Minnesota, 55905
Canada3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 1240001
Montreal, Quebec, H4A 3J1
- Recruiting
Investigational Site Number : 1240002
Sherbrooke, Quebec, J1H 5N4
- Recruiting
Investigational Site Number : 1240005
Vancouver, British Columbia, V5Z 1L3
Israel3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3760004
Haifa, 3109601
- Recruiting
Investigational Site Number : 3760002
Jerusalem, 9112001
- Recruiting
Investigational Site Number : 3760001
Tel Aviv, Malopolskie, 6423906
Australia2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 0360002
Melbourne, Victoria, 3065
- Recruiting
Investigational Site Number : 0360001
Wollongong, New South Wales, 2500
France2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 2500002
Lille, 59037
- Recruiting
Investigational Site Number : 2500001
Nantes, 44093
Italy2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 3800001
Rozzano, Milano, 20089
- Recruiting
Investigational Site Number : 3800002
Torette, Ancona, 60020
Spain2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 7240002
Barcelona, Barcelona [Barcelona], 08035
- Recruiting
Investigational Site Number : 7240001
Madrid, 28040
About this study
Official title: A First-in-human, Open-label, Phase 1 Study to Evaluate the Safety, Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of Subcutaneous SAR446523, an Anti-GPRC5D ADCC-enhanced Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma
This is a first-in-human study of SAR446523 conducted in patients with RRMM.
The study consists of two parts:
Read more
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.
Read the detailed description
The study will be considered ongoing until the last participant last visit has occurred. Participants will be allowed to continue therapy until disease progression, unacceptable AEs, participant or Investigator's request to discontinue treatment.
- Conditions
- Plasma Cell Myeloma Refractory
- Being tested
- SAR446523
- Keywords
- anti-GPRC5D NK cell targeting therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR446523Drug
Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC)
| Study group | Role | What they receive |
|---|---|---|
| Part A (Dose escalation) | Experimental | Participants will receive SAR446523 Receives: Drug: SAR446523 |
| Part B Dose-1 (Dose optimization) | Experimental | Participants will receive SAR446523 Dose-1 Receives: Drug: SAR446523 |
| Part B Dose-2 (Dose optimization) | Experimental | Participants will receive SAR446523 Dose-2 Receives: Drug: SAR446523 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs)- Dose escalation (Part A)
The incidence of DLTs will be evaluated using NCI CTCAE version 5.0 criteria.
Measured: Cycle 1 (28 days)
Overall response rate (ORR) - Dose optimization (Part B)
ORR is defined as the proportion of participants with sCR, CR, VGPR, and PR assessed as per Investigator according to the 2016 IMWG response criteria.
Measured: 24 months after the Last Participant In (LPI)
Secondary outcomes (15)
Number of participants with treatment emergent adverse events (TEAEs), injection related reactions (IRRs), injection site reactions (ISRs), serious adverse events (SAEs), adverse event of special interests (AESIs)
Measured as per NCI CTCAE v 5.0
Measured: From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 5 years
Change from baseline in laboratory abnormalities
Measured as per NCI CTCAE v 5.0.
Measured: From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 5 years
ORR- Dose escalation (Part A)
ORR defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) assessed as per Investigator according to the 2016 International Myeloma Working Group (IMWG) response criteria.
Measured: 24 months after the Last Participant In (LPI)
VGPR or better rate
VGPR or better rate defined as the proportion of participants with sCR, CR, and VGPR assessed as per Investigator according to the 2016 IMWG response criteria.
Measured: 24 months after the Last Participant In (LPI)
Clinical benefit rate (CBR)
CBR defined as the rate of participants with confirmed sCR, CR, VGPR, or PR at any time or minimal response (MR) of at least 6 months from the first IMP administration determined per 2016 IMWG response criteria.
Measured: 24 months after the Last Participant In (LPI)
Duration of response (DoR)
DoR defined as the time from the date of the first response (PR or better) to the date of first documentation of progressive disease (PD) as defined in the 2016 IMWG response criteria, or date of death, whichever occurs first.
Measured: 24 months after the Last Participant In (LPI)
Time to response (TTR)
TTR defined as the time from the first administration of study IMP to the date of first response (PR or better) that is subsequently confirmed.
Measured: 24 months after the Last Participant In (LPI)
Progression free survival (PFS)
PFS defined as the time interval from the date of first administration of study IMP to the date of first documentation of PD per 2016 IMWG criteria assessed by study Investigator, or date of death from any cause, whichever comes first.
Measured: 24 months after the Last Participant In (LPI)
Minimal residual disease (MRD) status negativity
MRD status negative by nextgeneration sequencing (NGS) in bone marrow of participants with a response of CR (or VGPR in case of suspected interference).
Measured: 24 months after the Last Participant In (LPI)
Number of participants with symptomatic AEs -Part B
The incidence and evaluation of symptomatic AEs from participants' perspective will be measured by using specific items from National Cancer Institute (NCI) patient-reported outcome (PRO) common terminology criteria for adverse events (CTCAE) library.
Measured: From Cycle 1 Day 1 to 30 days after the date of the last study treatment administration i.e., approximately 5 years
Change from baseline in overall side effect bother as measured by the Functional Assessment of Cancer Therapy item 5 (FACT-GP5)- Part B
The FACT GP5 is an assessment focused on the overall side effect impact to inform the tolerability of a treatment. The FACT GP5 ("I am bothered by side effects of treatment") responses are given on a 5 point Likert type scale recalling the past 7 days. Higher scores indicate a higher degree of side effect bother.
Measured: From Cycle 1 Day 1 to 30 days after the date of the last study treatment administration i.e., approximately 5 years
Maximum observed concentration (Cmax)
To characterize the pharmacokinetics (PK) of SAR446523.
Measured: Multiple timepoints from Cycle 1 Day 1 to Cycle 1 Day 8 (cycle 1=28 days)
First time to reach Cmax (tmax)
To characterize the PK of SAR446523.
Measured: Multiple timepoints from Cycle 1 Day 1 to Cycle 1 Day 8 (cycle 1=28 days)
Area under the concentration versus time curve calculated from 0 to 168 hours (AUC0-168h)
To characterize the PK of SAR446523.
Measured: Multiple timepoints from Cycle 1 Day 1 to Cycle 1 Day 8 (cycle 1=28 days)
Proportion of participants with presence of anti-drug antibody (ADA) against SAR446523.
To evaluate potential immunogenicity.
Measured: From Cycle 1 Day 1 to 30 days after the date of the last study treatment administration i.e., approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start30 Oct 2024
- Primary completion16 May 2031 (estimated)
- Study completion16 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell Myeloma RefractoryStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study is non-randomized for part A but randomized for part B. Study drug will be assigned in sequential manner in Part A but parallel assignment in Part B.
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630806
- Sponsor's protocol ID
- TED18162
- Other IDs
- U1111-1301-4016, 2024-511667-28
- Status last verified
- Mar 2026
- First submitted
- 3 Oct 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Open-label, Phase 1 Study to Evaluate the Safety, Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of Subcutaneous SAR446523, an Anti-GPRC5D ADCC-enhanced Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06630806
- Acronym / sponsor ID
- TED18162
- Conditions
- Plasma Cell Myeloma Refractory
- Keywords
- anti-GPRC5D NK cell targeting therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 16 May 2031 (estimated)
- Study completion
- 16 May 2031 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be considered ongoing until the last participant last visit has occurred. Participants will be allowed to continue therapy until disease progression, unacceptable AEs, participant or Investigator's request to discontinue treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Study is non-randomized for part A but randomized for part B. Study drug will be assigned in sequential manner in Part A but parallel assignment in Part B.
| Arm | Type | Receives |
|---|---|---|
| Part A (Dose escalation) | Experimental | Drug: SAR446523Participants will receive SAR446523 |
| Part B Dose-1 (Dose optimization) | Experimental | Drug: SAR446523Participants will receive SAR446523 Dose-1 |
| Part B Dose-2 (Dose optimization) | Experimental | Drug: SAR446523Participants will receive SAR446523 Dose-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR446523Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC) | Drug | Part A (Dose escalation), Part B Dose-1 (Dose optimization), Part B Dose-2 (Dose optimization) |
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs)- Dose escalation (Part A)
Time frame: Cycle 1 (28 days)
The incidence of DLTs will be evaluated using NCI CTCAE version 5.0 criteria.
Overall response rate (ORR) - Dose optimization (Part B)
Time frame: 24 months after the Last Participant In (LPI)
ORR is defined as the proportion of participants with sCR, CR, VGPR, and PR assessed as per Investigator according to the 2016 IMWG response criteria.
15 secondary outcomes
Number of participants with treatment emergent adverse events (TEAEs), injection related reactions (IRRs), injection site reactions (ISRs), serious adverse events (SAEs), adverse event of special interests (AESIs)
Time frame: From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 5 years
Change from baseline in laboratory abnormalities
Time frame: From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 5 years
ORR- Dose escalation (Part A)
Time frame: 24 months after the Last Participant In (LPI)
VGPR or better rate
Time frame: 24 months after the Last Participant In (LPI)
Clinical benefit rate (CBR)
Time frame: 24 months after the Last Participant In (LPI)
Duration of response (DoR)
Time frame: 24 months after the Last Participant In (LPI)
Time to response (TTR)
Time frame: 24 months after the Last Participant In (LPI)
Progression free survival (PFS)
Time frame: 24 months after the Last Participant In (LPI)
Minimal residual disease (MRD) status negativity
Time frame: 24 months after the Last Participant In (LPI)
Number of participants with symptomatic AEs -Part B
Time frame: From Cycle 1 Day 1 to 30 days after the date of the last study treatment administration i.e., approximately 5 years
Change from baseline in overall side effect bother as measured by the Functional Assessment of Cancer Therapy item 5 (FACT-GP5)- Part B
Time frame: From Cycle 1 Day 1 to 30 days after the date of the last study treatment administration i.e., approximately 5 years
Maximum observed concentration (Cmax)
Time frame: Multiple timepoints from Cycle 1 Day 1 to Cycle 1 Day 8 (cycle 1=28 days)
First time to reach Cmax (tmax)
Time frame: Multiple timepoints from Cycle 1 Day 1 to Cycle 1 Day 8 (cycle 1=28 days)
Area under the concentration versus time curve calculated from 0 to 168 hours (AUC0-168h)
Time frame: Multiple timepoints from Cycle 1 Day 1 to Cycle 1 Day 8 (cycle 1=28 days)
Proportion of participants with presence of anti-drug antibody (ADA) against SAR446523.
Time frame: From Cycle 1 Day 1 to 30 days after the date of the last study treatment administration i.e., approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- TED18162 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
19 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR446523 in people with Plasma Cell Myeloma Refractory, run by Sanofi at 19 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada, Israel, Australia, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicities (DLTs)- Dose escalation (Part A) (time frame: Cycle 1 (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.