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NCT06297226 | RECRUITING | Multiple Myeloma

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

Brief 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.

Condition or disease

Multiple Myeloma

Intervention/treatment

Arlocabtagene Autoleucel (BMS-986393)

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 175 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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)
Actual Study Start Date : 2024-03-21
Estimated Primary Completion Date : 2027-06-30
Estimated Study Completion Date : 2032-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
    • Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma

    Location Details

    NCT06297226

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, Albama

    University of Alabama at Birmingham

    Birmingham, Albama, United States, 35294-3300

    RECRUITING

    United States, Arizona

    Banner MD Anderson Cancer Center

    Gilbert, Arizona, United States, 85234

    RECRUITING

    United States, Arkansa

    University of Arkansas for Medical Sciences

    Little Rock, Arkansa, United States, 72205

    RECRUITING

    United States, California

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

    Los Angeles, California, United States, 90095

    RECRUITING

    United States, California

    UCSF Helen Diller Medical Center at Parnassus Heights

    San Francisco, California, United States, 94143

    RECRUITING

    United States, Colorado

    Colorado Blood Cancer Institute

    Denver, Colorado, United States, 80218

    RECRUITING

    United States, Florida

    Mayo Clinic in Florida

    Jacksonville, Florida, United States, 32224

    RECRUITING

    United States, Florida

    Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, United States, 33176

    RECRUITING

    United States, Florida

    Moffitt Cancer Center

    Tampa, Florida, United States, 33612

    RECRUITING

    United States, Georgia

    Winship Cancer Institute of Emory University

    Atlanta, Georgia, United States, 30322

    RECRUITING

    United States, Georgia

    Northside Hospital

    Atlanta, Georgia, United States, 30342

    RECRUITING

    United States, Illinois

    Northwestern Memorial Hospital

    Chicago, Illinois, United States, 60611

    RECRUITING

    United States, Illinois

    University of Chicago Medical Center

    Chicago, Illinois, United States, 60637

    RECRUITING

    United States, Iowa

    University of Iowa

    Iowa City, Iowa, United States, 52242

    RECRUITING

    United States, Kansas

    The University of Kansas Cancer Center - Westwood

    Westwood, Kansas, United States, 66205

    RECRUITING

    United States, Kentucky

    Norton Women's and Children's Hospital

    Louisville, Kentucky, United States, 40207

    WITHDRAWN

    United States, Maryland

    Local Institution - 0065

    Baltimore, Maryland, United States, 21218

    RECRUITING

    United States, Massachusetts

    Massachusetts General Hospital

    Boston, Massachusetts, United States, 02114

    RECRUITING

    United States, Massachusetts

    Dana-Farber Cancer Institute

    Boston, Massachusetts, United States, 02215

    RECRUITING

    United States, Minnesota

    Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota, United States, 55905

    RECRUITING

    United States, Missouri

    Washington University School of Medicine

    Saint Louis, Missouri, United States, 63110

    RECRUITING

    United States, New Jersey

    Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, United States, 08901

    RECRUITING

    United States, New York

    Roswell Park Cancer Institute

    Buffalo, New York, United States, 14263

    RECRUITING

    United States, New York

    Icahn School of Medicine at Mount Sinai

    New York, New York, United States, 10029

    RECRUITING

    United States, New York

    Memorial Sloan Kettering Cancer Center

    New York, New York, United States, 10065

    RECRUITING

    United States, North Carolina

    University of North Carolina Medical Center

    Chapel Hill, North Carolina, United States, 27599

    WITHDRAWN

    United States, North Carolina

    Local Institution - 0067

    Charlotte, North Carolina, United States, 28204

    RECRUITING

    United States, Ohio

    Oncology Hematology Care

    Cincinnati, Ohio, United States, 45242

    RECRUITING

    United States, Ohio

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

    Columbus, Ohio, United States, 43210

    RECRUITING

    United States, Oregon

    Oregon Health and Science University

    Portland, Oregon, United States, 97239

    NOT YET RECRUITING

    United States, Pennsylvania

    Local Institution - 0070

    Philadelphia, Pennsylvania, United States, 19107

    RECRUITING

    United States, Tennessee

    Tennessee Oncology

    Nashville, Tennessee, United States, 37203

    NOT YET RECRUITING

    United States, Tennessee

    Local Institution - 0043

    Nashville, Tennessee, United States, 37232

    WITHDRAWN

    United States, Texas

    Local Institution - 0069

    Austin, Texas, United States, 78704

    RECRUITING

    United States, Texas

    UT Southwestern Medical Center

    Dallas, Texas, United States, 75390

    RECRUITING

    United States, Texas

    University of Texas MD Anderson Cancer Center

    Houston, Texas, United States, 77030

    RECRUITING

    United States, Texas

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

    San Antonio, Texas, United States, 78229

    RECRUITING

    United States, Utah

    LDS Hospital

    Salt Lake City, Utah, United States, 84143

    RECRUITING

    United States, Virginia

    Virginia Oncology Associates

    Norfolk, Virginia, United States, 23502

    RECRUITING

    United States, Washington

    Fred Hutchinson Cancer Center

    Seattle, Washington, United States, 98109

    RECRUITING

    United States, Wisconsin

    University Hospital and UW Health Clinics

    Madison, Wisconsin, United States, 53792

    NOT YET RECRUITING

    Australia, New South Wales

    Local Institution - 0077

    Camperdown, New South Wales, Australia, 2050

    NOT YET RECRUITING

    Australia, Queensland

    Local Institution - 0075

    Brisbane, Queensland, Australia, 4029

    NOT YET RECRUITING

    Australia, Victoria

    Local Institution - 0074

    Melbourne, Victoria, Australia, 3004

    NOT YET RECRUITING

    Australia, Victoria

    Local Institution - 0076

    Melbourne, Victoria, Australia, 3065

    RECRUITING

    Canada, Alberta

    Tom Baker Cancer Center

    Calgary, Alberta, Canada, T2N 4N2

    RECRUITING

    Canada, Quebec

    McGill University Health Centre

    Montréal, Quebec, Canada, H4A 3J1

    RECRUITING

    Japan, Aichi

    Nagoya City University Hospital

    Nagoya, Aichi, Japan, 467-8602

    RECRUITING

    Japan, Hyogo

    Hyogo Medical University Hospital

    Nishinomiya, Hyogo, Japan, 663-8501

    RECRUITING

    Japan,

    Chiba University Hospital

    Chiba, Japan, 260-8677

    RECRUITING

    Japan,

    University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, Japan, 602-8566

    RECRUITING

    Japan,

    Japanese Red Cross Medical Center

    Tokyo, Japan, 150-8935