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Back|NCT06297226Recruiting
Official Title

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)

Phase
Phase 2
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Enrollment
230
Timeline
Mar 2024 → Jun 2032
About This Study

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 Criteria

Inclusion Criteria

  • 1Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
  • 2Received 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).
  • 3Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
  • 4Participants must have measurable disease during screening.
  • 5Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria

  • 1Active or history of central nervous system involvement with MM.
  • 2Active 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.
  • 3Received 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.

Locations

52 sites participating in this study

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

Recruiting

Nisha Joseph, Site 0009

502-608-5503

University of Alabama at Birmingham

Birmingham, Alabama 35294-3300

Recruiting

Susan Bal, Site 0001

205-934-1908

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

Recruiting

Ambuga Badari, Site 0025

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →