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A Phase 2, Open-Label, Multicenter Study of 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 BMS-986393 in participants with relapsed or refractory multiple myeloma.
Trial Eligibility
Inclusion Criteria * Documented diagnosis of multiple Mmyeloma (MM) as per International Myeloma Working Group (IMWG) criteria. * Received at least 4 classes of MM treatment \[including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, and anti-B cell maturation antigen (BCMA) therapy\], and at least 3 prior lines of therapy (LOT). * Documented disease progression during or after their last anti-myeloma regimen as per IMWG. * Participants must have measurable disease during screening. * 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)
Interventions
Locations Recruiting
Local Institution - 0001
United States, Alabama, Birmingham
Local Institution - 0025
United States, Arizona, Gilbert
Local Institution - 0037
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
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