Phase
Condition
Cancer
Leukemia
Lymphoproliferative Disorders
Treatment
SAR446523
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with a documented diagnosis of multiple myeloma (MM) with measurabledisease.
Contraceptive use by men and women should be consistent with local regulationsregarding 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, andmust be either relapsed or refractory to the above therapies, or are intolerant tothem.
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 isallowed.
Dose optimization (Part B)
Participants must have received at least 3 prior lines of antimyeloma therapy and beeither relapsed or refractory to immunomodulator (IMiD), proteasome inhibitor (PI),anti CD38 monoclonal antibody (mAb), and anti BCMA targeting agent or are intolerantto them.
Note: In Part B, prior exposure to antiGPRC5D therapy is not allowed.
Exclusion
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, activepolyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, active plasma cell leukemia. Participants with central nervoussystem involvement or with clinical signs of meningeal involvement of multiplemyeloma.
Systemic antimyeloma treatment within 14 days before the first study treatmentadministration.
Prior treatment with natural killer (NK)-cell engaging therapy (such as monoclonalantibody with antibody-dependent cellular cytotoxicity as primary mechanism ofaction) 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
Study Description
Connect with a study center
Investigational Site Number : 0360001
Wollongong, New South Wales 2500
AustraliaActive - Recruiting
Investigational Site Number : 0360001
Wollongong 2171507, New South Wales 2155400 2500
AustraliaSite Not Available
Investigational Site Number : 0360002
Melbourne, Victoria 3065
AustraliaActive - Recruiting
Investigational Site Number : 0360002
Fitzroy 2166584, Victoria 2145234 3065
AustraliaSite Not Available
Investigational Site Number : 0360002
Melbourne 2158177, Victoria 2145234 3065
AustraliaSite Not Available
Investigational Site Number : 1240005
Vancouver, British Columbia V5Z 1L3
CanadaActive - Recruiting
Investigational Site Number : 1240001
Montreal, Quebec H4A 3J1
CanadaActive - Recruiting
Investigational Site Number : 1240002
Sherbrooke, Quebec J1H 5N4
CanadaActive - Recruiting
Investigational Site Number : 1240001
Montreal 6077243, Quebec 6115047 H4A 3J1
CanadaSite Not Available
Investigational Site Number : 1240002
Sherbrooke 6146143, Quebec 6115047 J1H 5N4
CanadaSite Not Available
Investigational Site Number : 2500002
Lille, 59037
FranceActive - Recruiting
Investigational Site Number : 2500002
Lille 2998324, 59037
FranceSite Not Available
Investigational Site Number : 2500001
Nantes, 44093
FranceActive - Recruiting
Investigational Site Number : 2500001
Nantes 2990969, 44093
FranceSite Not Available
Investigational Site Number : 3760001
Tel Aviv, Malopolskie 6423906
IsraelActive - Recruiting
Investigational Site Number : 3760001
Tel Aviv 293397, Malopolskie 6423906
IsraelSite Not Available
Investigational Site Number : 3760004
Haifa, 3109601
IsraelActive - Recruiting
Investigational Site Number : 3760004
Haifa 294801, 3109601
IsraelSite Not Available
Investigational Site Number : 3760002
Jerusalem, 9112001
IsraelActive - Recruiting
Investigational Site Number : 3760002
Jerusalem 281184, 9112001
IsraelSite Not Available
Investigational Site Number : 3800002
Torette, Ancona 60020
ItalyActive - Recruiting
Investigational Site Number : 3800001
Rozzano, Milano 20089
ItalyActive - Recruiting
Investigational Site Number : 3800001
Rozzano 3168837, Milano 20089
ItalySite Not Available
Investigational Site Number : 3800001
Rozzano (MI) 3168837, Milano 20089
ItalySite Not Available
Investigational Site Number : 3800002
Ancona 3183089, Puerto Rico 60126
ItalySite Not Available
Investigational Site Number : 3800001
Rozzano (MI), 20089
ItalySite Not Available
Investigational Site Number : 7240002
Barcelona, Barcelona [Barcelona] 08035
SpainActive - Recruiting
Investigational Site Number : 7240002
Barcelona 3128760, Barcelona [Barcelona] 08035
SpainSite Not Available
Investigational Site Number : 7240001
Madrid, 28040
SpainActive - Recruiting
Investigational Site Number : 7240001
Madrid 3117735, 28040
SpainSite Not Available
Mayo Clinic in Arizona - Phoenix- Site Number : 8400005
Phoenix, Arizona 85054
United StatesActive - Recruiting
Mayo Clinic in Arizona - Phoenix- Site Number : 8400005
Phoenix 5308655, Arizona 5551752 85054
United StatesSite Not Available
Mayo Clinic in Florida- Site Number : 8400003
Jacksonville, Florida 32224
United StatesActive - Recruiting
Mayo Clinic in Florida- Site Number : 8400003
Jacksonville 4160021, Florida 4155751 32224
United StatesSite Not Available
Mayo Clinic in Rochester - Minnesota- Site Number : 8400004
Rochester, Minnesota 55905
United StatesActive - Recruiting
Mayo Clinic in Rochester - Minnesota- Site Number : 8400004
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Hackensack Meridian School of Medicine- Site Number : 8400001
Hackensack, New Jersey 07601
United StatesSite Not Available
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400001
Hackensack 5098706, New Jersey 5101760 07601
United StatesSite Not Available
Hackensack Meridian School of Medicine- Site Number : 8400001
Hackensack 5098706, New Jersey 5101760 07601
United StatesActive - Recruiting
Thomas Jefferson University Hospital- Site Number : 8400002
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Thomas Jefferson University Hospital- Site Number : 8400002
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available

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