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RECRUITINGPhase 2INTERVENTIONAL

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

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Inclusion Criteria - Documented diagnosis of multiple myeloma (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, anti-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 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. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded. - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria * Documented diagnosis of multiple myeloma (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, anti-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 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. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded. * 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.

Treatments Being Tested

BIOLOGICAL

Arlocabtagene Autoleucel

Specified dose on specified days

Locations (20)

University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)
Los Angeles, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
Norton Women's and Children's Hospital
Louisville, Kentucky, United States
Local Institution - 0065
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States