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] (NCT06297226)

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 phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Sueh-Li Lim

Key inclusion data

Inclusion Criteria: Documented diagnosis of multiple myeloma (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, anti-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 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. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded; 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.