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

J

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)

150 participants in 1 patient group

BMS-986393
Experimental group
Treatment:
Biological: BMS-986393

Trial contacts and locations

42

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Central trial contact

First line of the email MUST contain NCT # and Site #.; BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Data sourced from clinicaltrials.gov

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