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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)


Outcome Timeframe Up to approximately 5 years

NCTID NCT06297226

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2024-03-21

Completion Date 2026-10-02

Enrollment Target 150

Interventions

BIOLOGICAL BMS-986393

Locations Recruiting

Local Institution - 0001

United States, Alabama, Birmingham


Local Institution - 0025

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


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