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

Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Sponsor score: 0

ClinicalTrials ID:NCT06297226

This clinical trial assesses the safety and efficacy of BMS-986393, a GPRC5D-directed CAR T cell therapy, in adults with relapsed or refractory multiple myeloma. Participants must meet specific inclusion criteria and not fall under exclusion criteria. The intervention involves administering a specified dose of BMS-986393 on designated days.

Patient Parameters

Program Overview

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

  • 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.

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham35294-3300BirminghamAlabama
Banner MD Anderson Cancer Center85234GilbertArizona
University of Arkansas for Medical Sciences72205Little RockArkansas
UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)90095Los AngelesCalifornia
UCSF Helen Diller Medical Center at Parnassus Heights94143San FranciscoCalifornia
Colorado Blood Cancer Institute80218DenverColorado
Local Institution - 006232224JacksonvilleFlorida
Miami Cancer Institute at Baptist Health, Inc.33176MiamiFlorida
Moffitt Cancer Center33612TampaFlorida
Winship Cancer Institute of Emory University30322AtlantaGeorgia

Get This Program In Your Inbox

You can sign up and apply your patients for this program.