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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


Outcome Timeframe Up to approximately 5 years

NCTID NCT06297226

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2024-03-21

Completion Date 2027-06-30

Enrollment Target 175

Interventions

BIOLOGICAL Arlocabtagene Autoleucel (BMS-986393)

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?

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