Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)

Juno Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Multiple Myeloma

Treatments: Biological: BMS-986393

Study type: Interventional

Funder types: Industry

Identifiers

NCT06297226

CA088-1000

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

BMS-986393

Experimental group

Treatment:

Biological: BMS-986393