Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT06297226
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
230 participants
INTERVENTIONAL
2024-03-21
2032-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arlocabtagene Autoleucel Cohort 1
Arlocabtagene Autoleucel
Specified dose on specified days
Arlocabtagene Autoleucel Cohort 2
Arlocabtagene Autoleucel
Specified dose on specified days
Interventions
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Arlocabtagene Autoleucel
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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.
18 Years
ALL
No
Sponsors
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Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Washington University School of Medicine
St Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Local Institution - 0067
Charlotte, North Carolina, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Local Institution - 0070
Philadelphia, Pennsylvania, United States
Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Local Institution - 0069
Austin, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute
San Antonio, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University Hospital and UW Health Clinics
Madison, Wisconsin, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Local Institution - 0075
Brisbane, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
St Vincent's Hospital
Melbourne, Victoria, Australia
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, Japan
Chiba University Hospital
Chiba, , Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, , Japan
Japanese Red Cross Medical Center
Tokyo, , Japan
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Susan Bal, Site 0001
Role: primary
Ambuga Badari, Site 0025
Role: primary
Sharmilan Thanendrarajan, Site 0037
Role: primary
Sarah Larson, Site 0028
Role: primary
Anupama Kumar, Site 0018
Role: primary
Tara Gregory, Site 0049
Role: primary
Vivek Roy, Site 0062
Role: primary
George Nahas, Site 0045
Role: primary
Ciara Freeman, Site 0029
Role: primary
Nisha Joseph, Site 0009
Role: primary
Scott Solomon, Site 0004
Role: primary
Seema Singhal, Site 0005
Role: primary
Andrzej Jakubowiak, Site 0056
Role: primary
Chris Strouse, Site 0019
Role: primary
Leyla Shune, Site 0016
Role: primary
Don Stevens, Site 0026
Role: primary
Diana Cirstea, Site 0039
Role: primary
Omar Nadeem, Site 0036
Role: primary
Taxiarchis Kourelis, Site 0033
Role: primary
Michael Slade, Site 0010
Role: primary
Mansi Shah, Site 0034
Role: primary
Ehsan Malek, Site 0046
Role: primary
Adriana Rossi, Site 0002
Role: primary
Sham Mailankody, Site 0003
Role: primary
Eben Lichtman, Site 0031
Role: primary
James Essell, Site 0054
Role: primary
Srinivas Devarakonda, Site 0032
Role: primary
Amrita Desai, Site 0038
Role: primary
Site 0070
Role: primary
Jesus Berdeja, Site 0066
Role: primary
Muhamed Baljevic, Site 0043
Role: primary
Larry Anderson, Site 0035
Role: primary
Krina Patel, Site 0027
Role: primary
Paul Shaughnessy, Site 0055
Role: primary
Bradley Hunter, Site 0050
Role: primary
gary Simmons, Site 0068
Role: primary
Rahul Banerjee, Site 0011
Role: primary
Zhubin Gahvari, Site 0015
Role: primary
Joy Ho, Site 0077
Role: primary
Site 0075
Role: primary
Shafqat Inam, Site 0074
Role: primary
Hang Quach, Site 0076
Role: primary
Nizar Bahlis, Site 0020
Role: primary
Michael Sebag, Site 0021
Role: primary
Shinsuke Iida, Site 0057
Role: primary
Satoshi Yoshihara, Site 0058
Role: primary
Emiko Sakaida, Site 0061
Role: primary
Junya Kuroda, Site 0059
Role: primary
Tadao Ishida, Site 0060
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA088-1000
Identifier Type: -
Identifier Source: org_study_id