Trial Title:
Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma
NCT ID:
NCT06297226
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
BMS-986393
CAR T Cell Therapy
RRMM
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
BMS-986393
Description:
Specified dose on specified days
Arm group label:
BMS-986393
Other name:
CC-95266,
Other name:
GPRC5D CAR T cells
Summary:
The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in
participants with relapsed or refractory multiple myeloma.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Local Institution - 0001
Address:
City:
Birmingham
Zip:
35294-3300
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0001
Facility:
Name:
Local Institution - 0025
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0025
Facility:
Name:
University of Arkansas for Medical Sciences
Address:
City:
Little Rock
Zip:
72205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sharmilan Thanendrarajan, Site 0037
Phone:
501-526-6000
Facility:
Name:
UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sarah Larson, Site 0028
Phone:
310-829-5471
Facility:
Name:
UCSF Helen Diller Medical Center at Parnassus Heights
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anupama Kumar, Site 0018
Phone:
415-514-0768
Facility:
Name:
Colorado Blood Cancer Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tara Gregory, Site 0049
Phone:
720-754-4800
Facility:
Name:
Local Institution - 0062
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0062
Facility:
Name:
Miami Cancer Institute at Baptist Health, Inc.
Address:
City:
Miami
Zip:
33176
Country:
United States
Status:
Recruiting
Contact:
Last name:
George Nahas, Site 0045
Phone:
201-310-8558
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ciara Freeman, Site 0029
Phone:
813-745-2475
Facility:
Name:
Winship Cancer Institute of Emory University
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nisha Joseph, Site 0009
Phone:
502-608-5503
Facility:
Name:
Northside Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Status:
Recruiting
Contact:
Last name:
Scott Solomon, Site 0004
Phone:
404-255-1930
Facility:
Name:
Local Institution - 0005
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0005
Facility:
Name:
Local Institution - 0056
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0056
Facility:
Name:
University of Iowa
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chris Strouse, Site 0019
Phone:
630-917-8956
Facility:
Name:
The University of Kansas Cancer Center - Westwood
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Leyla Shune, Site 0016
Phone:
913-588-6029
Facility:
Name:
Norton Women's and Children's Hospital
Address:
City:
Saint Matthews
Zip:
40207
Country:
United States
Status:
Recruiting
Contact:
Last name:
Don Stevens, Site 0026
Phone:
502-899-3366
Facility:
Name:
Local Institution - 0065
Address:
City:
Baltimore
Zip:
21218
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0065
Facility:
Name:
Local Institution - 0039
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0039
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Omar Nadeem, Site 0036
Phone:
617-632-3000
Facility:
Name:
Local Institution - 0033
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0033
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Slade, Site 0010
Phone:
314-454-8304
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mansi Shah, Site 0034
Phone:
732-209-5479
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ehsan Malek, Site 0046
Phone:
716-845-8722
Facility:
Name:
Icahn School of Medicine at Mount Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Contact:
Last name:
Adriana Rossi, Site 0002
Phone:
646-962-6500
Facility:
Name:
Local Institution - 0003
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0003
Facility:
Name:
University of North Carolina Medical Center
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eben Lichtman, Site 0031
Phone:
617-842-6051
Facility:
Name:
Local Institution - 0067
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0067
Facility:
Name:
Oncology Hematology Care
Address:
City:
Cincinnati
Zip:
45242
Country:
United States
Status:
Recruiting
Contact:
Last name:
James Essell, Site 0054
Phone:
513-686-5482
Facility:
Name:
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Srinivas Devarakonda, Site 0032
Phone:
570-423-0522
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amrita Desai, Site 0038
Phone:
503-494-0896
Facility:
Name:
Local Institution - 0066
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0066
Facility:
Name:
Local Institution - 0043
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0043
Facility:
Name:
Local Institution - 0069
Address:
City:
Austin
Zip:
78704
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0069
Facility:
Name:
Local Institution - 0035
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0035
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Krina Patel, Site 0027
Phone:
713-792-6662
Facility:
Name:
Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paul Shaughnessy, Site 0055
Phone:
210-575-6904
Facility:
Name:
LDS Hospital
Address:
City:
Salt Lake City
Zip:
84143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bradley Hunter, Site 0050
Phone:
801-419-6498
Facility:
Name:
Local Institution - 0068
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0068
Facility:
Name:
Local Institution - 0011
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0011
Facility:
Name:
University Hospital and UW Health Clinics
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Zhubin Gahvari, Site 0015
Phone:
608-262-9317
Facility:
Name:
Tom Baker Cancer Center
Address:
City:
Calgary
Zip:
T2N 4N2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Nizar Bahlis, Site 0020
Phone:
4032202801
Facility:
Name:
McGill University Health Centre
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Michael Sebag, Site 0021
Phone:
514-934-1934-31558
Facility:
Name:
Local Institution - 0057
Address:
City:
Nagoya
Zip:
467-8602
Country:
Japan
Status:
Not yet recruiting
Contact:
Last name:
Site 0057
Facility:
Name:
Local Institution - 0058
Address:
City:
Nishinomiya
Zip:
663-8501
Country:
Japan
Status:
Not yet recruiting
Contact:
Last name:
Site 0058
Facility:
Name:
Local Institution - 0061
Address:
City:
Chiba
Zip:
260-8677
Country:
Japan
Status:
Not yet recruiting
Contact:
Last name:
Site 0061
Facility:
Name:
Local Institution - 0059
Address:
City:
Kyoto
Zip:
602-8566
Country:
Japan
Status:
Not yet recruiting
Contact:
Last name:
Site 0059
Facility:
Name:
Local Institution - 0060
Address:
City:
Tokyo
Zip:
150-8935
Country:
Japan
Status:
Not yet recruiting
Contact:
Last name:
Site 0060
Start date:
March 21, 2024
Completion date:
June 4, 2030
Lead sponsor:
Agency:
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Agency class:
Industry
Source:
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06297226
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06297226.html