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Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma

RecruitingPhase 2

A Phase 2, Open-Label, Multicenter Study of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria

* Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
* Received at least 4 classes of MM treatment \[including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, anti-BCMA therapy, and at least 3 prior lines of therapy (LOT).
* Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
* Participants must have measurable disease during screening.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria

* Active or history of central nervous system involvement with MM.
* Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded.
* Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis.
* Other protocol-defined Inclusion/Exclusion criteria apply.

About the study

The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.

What is being tested

Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Participants: 230 · Started: Mar 21, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06297226

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham
ArizonaBanner MD Anderson Cancer Center, Gilbert
ArkansasUniversity of Arkansas for Medical Sciences, Little Rock
CaliforniaUCLA Hematology/Oncology - Westwood (Building 200 Suite 214), Los Angeles
UCSF Helen Diller Medical Center at Parnassus Heights, San Francisco
ColoradoColorado Blood Cancer Institute, Denver
FloridaMayo Clinic in Florida, Jacksonville
Miami Cancer Institute at Baptist Health, Inc., Miami
Moffitt Cancer Center, Tampa
GeorgiaNorthside Hospital, Atlanta
Winship Cancer Institute of Emory University, Atlanta
IllinoisNorthwestern Memorial Hospital, Chicago
University of Chicago Medical Center, Chicago
IowaUniversity of Iowa, Iowa City
KansasThe University of Kansas Cancer Center - Westwood, Westwood
KentuckyNorton Women's and Children's Hospital, Louisville
MassachusettsDana-Farber Cancer Institute, Boston
Massachusetts General Hospital, Boston
MinnesotaMayo Clinic in Rochester, Minnesota, Rochester
MissouriWashington University School of Medicine, St Louis
New JerseyRutgers Cancer Institute of New Jersey, New Brunswick
New YorkRoswell Park Cancer Institute, Buffalo
Icahn School of Medicine at Mount Sinai, New York
Memorial Sloan Kettering Cancer Center, New York
North CarolinaUniversity of North Carolina Medical Center, Chapel Hill
OhioOncology Hematology Care, Cincinnati
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center, Columbus
OregonOregon Health and Science University, Portland
PennsylvaniaSidney Kimmel Cancer Center - Jefferson Health, Philadelphia
TennesseeTennessee Oncology, Nashville
Vanderbilt University Medical Center, Nashville
TexasUT Southwestern Medical Center, Dallas
University of Texas MD Anderson Cancer Center, Houston
Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute, San Antonio
UtahLDS Hospital, Salt Lake City
VirginiaVirginia Oncology Associates, Norfolk
WashingtonFred Hutchinson Cancer Center, Seattle
WisconsinUniversity of Wisconsin Carbone Cancer Center - University Hospital, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.