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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arlocabtagene Autoleucel Cohort 1
  • Biological: Arlocabtagene Autoleucel
    Specified dose on specified days
    Other names:
    • CC-95266,
    • GPRC5D CAR T cells
    • BMS-986393
    • Arlo-cel
Experimental
Arlocabtagene Autoleucel Cohort 2
  • Biological: Arlocabtagene Autoleucel
    Specified dose on specified days
    Other names:
    • CC-95266,
    • GPRC5D CAR T cells
    • BMS-986393
    • Arlo-cel

Recruiting Locations

University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35294-3300
Contact:
Susan Bal, Site 0001
205-934-1908

Banner MD Anderson Cancer Center
Gilbert 5295903, Arizona 5551752 85234
Contact:
Ambuga Badari, Site 0025

University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205
Contact:
Sharmilan Thanendrarajan, Site 0037
000-000-0000

UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)
Los Angeles 5368361, California 5332921 90095
Contact:
Sarah Larson, Site 0028
310-829-5471

UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco 5391959, California 5332921 94143
Contact:
Anupama Kumar, Site 0018
415-514-0768

Colorado Blood Cancer Institute
Denver 5419384, Colorado 5417618 80218
Contact:
Tara Gregory, Site 0049
720-754-4800

Mayo Clinic in Florida
Jacksonville 4160021, Florida 4155751 32224
Contact:
Vivek Roy, Site 0062
000-000-0000

Miami Cancer Institute at Baptist Health, Inc.
Miami 4164138, Florida 4155751 33176
Contact:
George Nahas, Site 0045
201-310-8558

Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
Contact:
Ciara Freeman, Site 0029
813-745-2475

Winship Cancer Institute of Emory University
Atlanta 4180439, Georgia 4197000 30322
Contact:
Nisha Joseph, Site 0009
502-608-5503

Northside Hospital
Atlanta 4180439, Georgia 4197000 30342
Contact:
Scott Solomon, Site 0004
404-255-1930

Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861 60611
Contact:
Seema Singhal, Site 0005
312-505-1290

University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637
Contact:
Andrzej Jakubowiak, Site 0056
734-276-2912

University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Contact:
Chris Strouse, Site 0019
630-917-8956

The University of Kansas Cancer Center - Westwood
Westwood 4281639, Kansas 4273857 66205
Contact:
Leyla Shune, Site 0016
913-588-6029

Norton Women's and Children's Hospital
Louisville 4299276, Kentucky 6254925 40207
Contact:
Don Stevens, Site 0026
502-899-3366

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Diana Cirstea, Site 0039
617-724-4000

Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
Contact:
Omar Nadeem, Site 0036
617-632-3000

Mayo Clinic in Rochester, Minnesota
Rochester 5043473, Minnesota 5037779 55905
Contact:
Taxiarchis Kourelis, Site 0033
855-776-0015

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Michael Slade, Site 0010
314-454-8304

Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901
Contact:
Mansi Shah, Site 0034
732-209-5479

Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638 14263
Contact:
Ehsan Malek, Site 0046
216-286-4441

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
Contact:
Adriana Rossi, Site 0002
646-962-6500

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
Contact:
Sham Mailankody, Site 0003
646-608-3712

University of North Carolina Medical Center
Chapel Hill 4460162, North Carolina 4482348 27599
Contact:
Eben Lichtman, Site 0031
617-842-6051

Oncology Hematology Care
Cincinnati 4508722, Ohio 5165418 45242
Contact:
James Essell, Site 0054
513-686-5482

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210
Contact:
Srinivas Devarakonda, Site 0032
570-423-0522

Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239
Contact:
Amrita Desai, Site 0038
503-494-0896

Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203
Contact:
Jesus Berdeja, Site 0066
615-329-0570

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
Contact:
Muhamed Baljevic, Site 0043
917-913-9166

UT Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390
Contact:
Larry Anderson, Site 0035
214-648-5906

University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Krina Patel, Site 0027
713-792-6662

Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute
San Antonio 4726206, Texas 4736286 78229
Contact:
Paul Shaughnessy, Site 0055
210-670-2313

LDS Hospital
Salt Lake City 5780993, Utah 5549030 84143
Contact:
Bradley Hunter, Site 0050
801-408-3729

Virginia Oncology Associates
Norfolk 4776222, Virginia 6254928 23502
Contact:
gary Simmons, Site 0068
757-461-7084

Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109
Contact:
Rahul Banerjee, Site 0011
206-606-1453

University Hospital and UW Health Clinics
Madison 5261457, Wisconsin 5279468 53792
Contact:
Zhubin Gahvari, Site 0015
608-262-9317

More Details

NCT ID
NCT06297226
Status
Recruiting
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.