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

Purpose

The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma.

Condition

  • Multiple Myeloma

Eligibility

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

Inclusion Criteria

  • Documented diagnosis of multiple Mmyeloma (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, and anti-B cell maturation antigen (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. - Participants must have measurable disease during screening. - 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

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
BMS-986393
  • Biological: BMS-986393
    Specified dose on specified days
    Other names:
    • CC-95266,
    • GPRC5D CAR T cells

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Sharmilan Thanendrarajan, Site 0037
501-526-6000

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Ehsan Malek, Site 0046
716-845-8722

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

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

Oncology Hematology Care
Cincinnati, Ohio 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, Ohio 43210
Contact:
Srinivas Devarakonda, Site 0032
570-423-0522

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

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

Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute
San Antonio, Texas 78229
Contact:
Paul Shaughnessy, Site 0055
210-575-6904

LDS Hospital
Salt Lake City, Utah 84143
Contact:
Bradley Hunter, Site 0050
801-419-6498

Fred Hutchinson Cancer Center
Seattle, Washington 98109
Contact:
Rahul Banerjee, Site 0011

University Hospital and UW Health Clinics
Madison, Wisconsin 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