Phase 2 Study of BMS-986393, a GPRC5D-directed CART-Cell Therapy, in Participants with Relapsed or Refractory Multiple Myeloma QUINTESSENTIAL
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What's the purpose of this trial?

The goal of this study is to learn more about the efficacy and safety of BMS-986363 in participants with relapsed or refractory multiple myeloma. 

This trial is currently open and accepting patients.

What will happen during the trial?

This trial is seeking approximately 150 participants. Participants will receive BMS-986393, an investigational, autologous CAR T-cell therapy. 

Participants will start the process of receiving BMS-986393 by undergoing a process called leukapheresis. This means that T cells will be removed from their blood and changed in a laboratory to become the investigational CAR T-cell therapy, BMS-986393. During the time that BMS-986393 is being manufactured, participants will receive mandatory bridging therapy. 

These investigational BMS-986393 CAR T-cells are then given back by intravenous infusion. Before receiving investigational BMS-986393, participants will receive a conditioning regimen of chemotherapy over three days. 

Participants may be hospitalized while receiving BMS-986393 or may receive investigational BMS-986393 at a qualified outpatient center depending on the investigators discretion. Participants will need to be closely monitored after receiving investigational BMS-986393. Patients will need to stay within a 30-minute transportation ride to the study site for at least 7 days and then within 120-minute transportation ride to the site and have a dedicated full-time caregiver or caregivers until 1 month after the investigational BMS-986393 infusion. 

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

  • have measurable disease as defined by the trial criteria. 
  • have received at least three prior lines of therapy for your myeloma, including a proteasome inhibitor, immunomodulatory agent, anti-CD38 monoclonal antibody, and at least one anti-BCMA targeted therapy.
  • have documented disease progression during or after your last line of therapy.
  • do not have central nervous system involvement of your myeloma.
  • have not previously received treatment with a GPRC5D targeted therapy.
  • have not received an autologous transplant in the last six months, or an allogeneic transplant in the last year. 
  • do not require urgent therapy due to rapidly progressing disease defined as:
    • significant worsening of kidney function, anemia, or skeletal complications from myeloma,
    • rapid rise in M-protein or Free Light Chains, 
    • clinical deterioration from myeloma.

Additional Trial Information

Phase 2

Enrollment: 150 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Alabama

University of Alabama at Birmingham O'Neal Comprehensive Cancer Center

Birmingham, AL

Not Yet Accepting

Arizona

Banner MD Anderson Cancer Center at Banner Gateway Medical Center

Gilbert, AZ

Not Yet Accepting

Arkansas

University of Arkansas for Medical Sciences (UAMS)

Little Rock, AR

Open and Accepting

California

UCSF Helen Diller Comprehensive Cancer Center University of California San Francisco

San Francisco, CA

Open and Accepting

UCLA Medical Center of Hematology/Oncology

Los Angeles, CA

Open and Accepting

Colorado

Colorado Blood Cancer Institute Sarah Cannon at Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Open and Accepting

Florida

Miami Cancer Institute Baptist Health South Florida

Miami, FL

Open and Accepting

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Northside Hospital (Atlanta)

Atlanta, GA

Open and Accepting

Illinois

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Not Yet Accepting

Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine

Chicago, IL

Not Yet Accepting

Indiana

Franciscan Health Cancer Center Indianapolis

Indianapolis, IN

Open and Accepting

Iowa

Holden Comprehensive Cancer Center - University of Iowa University of Iowa Hospitals and Clinics

Iowa City, IA

Open and Accepting

Kansas

University of Kansas Cancer Center

Kansas City, KS

Open and Accepting

Kentucky

Norton Cancer Institute (St. Matthews) St. Matthews Campus

Louisville, KY

Open and Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Open and Accepting

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Not Yet Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

New Jersey

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey

New Brunswick, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Not Yet Accepting

Roswell Park Cancer Institute

Buffalo, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

North Carolina

UNC Lineberger Comprehensive Cancer Center University of North Carolina

Chapel Hill, NC

Open and Accepting

Ohio

Oncology Hematology Care, Inc. - Blue Ash

Cincinnati, OH

Open and Accepting

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

Columbus, OH

Open and Accepting

Oregon

Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Open and Accepting

Tennessee

Vanderbilt-Ingram Cancer Center Henry-Joyce Cancer Clinic

Nashville, TN

Not Yet Accepting

Texas

The University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center

Dallas, TX

Not Yet Accepting

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Methodist Hospital

San Antonio, TX

Open and Accepting

Washington

Fred Hutchinson Cancer Research Center University of Washington Cancer Consortium / SCCA

Seattle, WA

Not Yet Accepting

Wisconsin

University of Wisconsin - Carbone Cancer Center University of Wisconsin Health

Madison, WI

Open and Accepting
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