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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)
Description
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.
Trial Eligibility
Inclusion Criteria * Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria. * Received at least 3 classes of MM treatment \[including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, 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. * 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.
Study Info
Organization
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Primary Outcome
Best overall response (BOR) of partial response (PR) or better
Interventions
Locations Recruiting
University of Alabama at Birmingham
United States, Alabama, Birmingham
Banner MD Anderson Cancer Center
United States, Arizona, Gilbert
University of Arkansas for Medical Sciences
United States, Arkansas, Little Rock
UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)
United States, California, Los Angeles
UCSF Helen Diller Medical Center at Parnassus Heights
United States, California, San Francisco
Interested in joining this trial?
Our dedicated patient navigators are here to support you by reviewing the eligibility criteria to see if you might qualify for this trial.
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