Title
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.

Objective
Primary Objectives:
- To evaluate the efficacy of BMS-986393 in participants with quadruple class exposed R/R MM having received at least 4 prior LOT.

Key Secondary Objective:
- To further evaluate the efficacy of BMS-986393 in quadruple class exposed R/R MM participants having received at least 4 prior and at least 3 prior LOT.

Secondary Objectives:
- To assess the safety of BMS-986393 among participants with R/R MM.
- To assess additional efficacy parameters.
- To assess the cellular kinetics of BMS-986393.
- To assess key MM symptoms, functioning, and overall HRQoL.
- To measure HCRU.

Treatment Experimental: BMS-986393 Biological: BMS-986393
Specified dose on specified days
Other Names:
CC-95266,
GPRC5D CAR T cells

Key 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.

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.

Applicable Disease Sites
Multiple Myeloma

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital