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)

ENROLLING
Protocol # :
24-044
Conditions
Multiple Myeloma
Phase
II
Disease Sites
Multiple Myeloma
Principal Investigator
Nadeem, Omar
Site Research Nurses
Alexander, Sara
Gammon, Marilyn
Lucia, Megan
Noyes, Sarah, M.
O'Malley, Sarah
Valles, Betsy, J.

Trial 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.

Eligibility Requirements

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.

24-044