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

Last updated: May 28, 2025
Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Overall Status: Active - Recruiting

Phase

2

Condition

Bone Neoplasm

Platelet Disorders

Bone Diseases

Treatment

BMS-986393

Arlocabtagene Autoleucel (BMS-986393)

Clinical Study ID

NCT06297226
CA088-1000
  • Ages > 18
  • All Genders

Study Summary

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

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.

Study Design

Total Participants: 175
Treatment Group(s): 2
Primary Treatment: BMS-986393
Phase: 2
Study Start date:
March 21, 2024
Estimated Completion Date:
June 30, 2032

Connect with a study center

  • Local Institution - 0077

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Local Institution - 0075

    Brisbane, Queensland 4029
    Australia

    Site Not Available

  • Local Institution - 0074

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Local Institution - 0076

    Melbourne, Victoria 3065
    Australia

    Site Not Available

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta T2N 4N2
    Canada

    Active - Recruiting

  • Local Institution - 0020

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Tom Baker Cancer Center

    Calgary, Alberta T2N 4N2
    Canada

    Active - Recruiting

  • Local Institution - 0021

    Montréal, Quebec H4A 3J1
    Canada

    Site Not Available

  • McGill University Health Centre

    Montréal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Local Institution - 0057

    Nagoya, Aichi 467-8602
    Japan

    Site Not Available

  • Nagoya City University Hospital

    Nagoya, Aichi 467-8602
    Japan

    Active - Recruiting

  • Hyogo Medical University Hospital

    Nishinomiya, Hyogo 663-8501
    Japan

    Active - Recruiting

  • Local Institution - 0058

    Nishinomiya, Hyogo 663-8501
    Japan

    Site Not Available

  • Chiba University Hospital

    Chiba, 260-8677
    Japan

    Active - Recruiting

  • Local Institution - 0061

    Chiba, 260-8677
    Japan

    Site Not Available

  • Local Institution - 0059

    Kyoto, 602-8566
    Japan

    Site Not Available

  • Japanese Red Cross Medical Center

    Tokyo, 150-8935
    Japan

    Active - Recruiting

  • Local Institution - 0060

    Tokyo, 150-8935
    Japan

    Site Not Available

  • Local Institution - 0001

    Birmingham, Alabama 35294-3300
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294-3300
    United States

    Active - Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • Local Institution - 0025

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Local Institution - 0037

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Local Institution - 0018

    San Francisco, California 94143
    United States

    Site Not Available

  • UCSF Helen Diller Medical Center at Parnassus Heights

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Local Institution - 0062

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Local Institution - 0045

    Miami, Florida 33176
    United States

    Site Not Available

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Local Institution - 0029

    Tampa, Florida 33612
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Local Institution - 0004

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Local Institution - 0009

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northside Hospital

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Local Institution - 0005

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Local Institution - 0056

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Northwestern University

    Evanston, Illinois 60208
    United States

    Site Not Available

  • Local Institution - 0019

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Local Institution - 0016

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Local Institution - 0016

    Westwood, Kansas 66205
    United States

    Site Not Available

  • The University of Kansas Cancer Center - Westwood

    Westwood, Kansas 66205
    United States

    Active - Recruiting

  • Norton Women's and Children's Hospital

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • Local Institution - 0026

    Saint Matthews, Kentucky 40207
    United States

    Site Not Available

  • Norton Women's and Children's Hospital

    Saint Matthews, Kentucky 40207
    United States

    Active - Recruiting

  • Local Institution - 0065

    Baltimore, Maryland 21218
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Local Institution - 0036

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Local Institution - 0039

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Local Institution - 0033

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Local Institution - 0010

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Local Institution - 0034

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Local Institution - 0046

    Buffalo, New York 14263
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Local Institution - 0002

    New York, New York 10029
    United States

    Site Not Available

  • Local Institution - 0003

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Local Institution - 0031

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Local Institution - 0067

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Local Institution - 0054

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Oncology Hematology Care

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Local Institution - 0032

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Local Institution - 0038

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Local Institution - 0070

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Local Institution - 0043

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Local Institution - 0066

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Local Institution - 0069

    Austin, Texas 78704
    United States

    Site Not Available

  • Local Institution - 0035

    Dallas, Texas 75390
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Local Institution - 0027

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Local Institution - 0055

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • LDS Hospital

    Salt Lake City, Utah 84143
    United States

    Active - Recruiting

  • Local Institution - 0050

    Salt Lake City, Utah 84143
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Local Institution - 0068

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Local Institution - 0011

    Seattle, Washington 98109
    United States

    Site Not Available

  • Local Institution - 0015

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University Hospital and UW Health Clinics

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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