A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Active SLE (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants
Status: Recruiting
Location: See all (76) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:
• Participants must meet EULAR/ACR 2019 criteria for SLE.
• Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months.
• Participants must have active disease when signing ICF.
Locations
United States
Alabama
Local Institution - 0009
NOT_YET_RECRUITING
Birmingham
California
Local Institution - 0038
NOT_YET_RECRUITING
Los Angeles
Local Institution - 0051
NOT_YET_RECRUITING
Los Angeles
Lucile Packard Children's Hospital
RECRUITING
Palo Alto
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Local Institution - 0002
NOT_YET_RECRUITING
Miami
Local Institution - 0073
WITHDRAWN
Orlando
Local Institution - 0008
NOT_YET_RECRUITING
Tampa
Local Institution - 0036
NOT_YET_RECRUITING
Tampa
Local Institution - 0062
NOT_YET_RECRUITING
Zephyrhills
Georgia
Local Institution - 0078
NOT_YET_RECRUITING
Atlanta
Local Institution - 0079
NOT_YET_RECRUITING
Atlanta
Hawaii
Local Institution - 0074
WITHDRAWN
Honolulu
Massachusetts
Local Institution - 0052
NOT_YET_RECRUITING
Boston
Minnesota
Local Institution - 0011
WITHDRAWN
Rochester
North Carolina
Local Institution - 0010
WITHDRAWN
Chapel Hill
Local Institution - 0065
NOT_YET_RECRUITING
Charlotte
New Jersey
Atlantic Health System Overlook Medical Center
RECRUITING
Summit
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Local Institution - 0005
NOT_YET_RECRUITING
New York
Local Institution - 0039
NOT_YET_RECRUITING
New York
Local Institution - 0040
NOT_YET_RECRUITING
New York
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Oklahoma
Local Institution - 0041
NOT_YET_RECRUITING
Oklahoma City
Texas
Baylor Scott and White Research Institute
RECRUITING
Dallas
Washington
Local Institution - 0007
NOT_YET_RECRUITING
Seattle
Other Locations
Argentina
Local Institution - 0016
NOT_YET_RECRUITING
Abb
Local Institution - 0017
WITHDRAWN
Abb
Local Institution - 0023
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 0077
NOT_YET_RECRUITING
Córdoba
Austria
Local Institution - 0031
NOT_YET_RECRUITING
Salzburg
Local Institution - 0037
NOT_YET_RECRUITING
Vienna
Belgium
Local Institution - 0020
NOT_YET_RECRUITING
Leuven
Brazil
Local Institution - 0021
NOT_YET_RECRUITING
São Paulo
Local Institution - 0022
NOT_YET_RECRUITING
São Paulo
Local Institution - 0058
NOT_YET_RECRUITING
São Paulo
Canada
Local Institution - 0045
NOT_YET_RECRUITING
Toronto
Local Institution - 0048
NOT_YET_RECRUITING
Vancouver
Denmark
Local Institution - 0047
NOT_YET_RECRUITING
Copenhagen
Local Institution - 0056
NOT_YET_RECRUITING
Odense
France
Local Institution - 0018
NOT_YET_RECRUITING
Montpellier
Local Institution - 0064
NOT_YET_RECRUITING
Paris
Local Institution - 0019
NOT_YET_RECRUITING
Rennes
Germany
Local Institution - 0026
NOT_YET_RECRUITING
Berlin
Local Institution - 0029
NOT_YET_RECRUITING
Cologne
Local Institution - 0027
NOT_YET_RECRUITING
Erlangen
Local Institution - 0028
NOT_YET_RECRUITING
Leipzig
Local Institution - 0030
NOT_YET_RECRUITING
Magdeburg
Israel
Local Institution - 0042
NOT_YET_RECRUITING
Jerusalem
Local Institution - 0043
NOT_YET_RECRUITING
Ramat Gan
Italy
Local Institution - 0032
NOT_YET_RECRUITING
Milan
Local Institution - 0070
NOT_YET_RECRUITING
Pisa
Local Institution - 0025
NOT_YET_RECRUITING
Rome
Local Institution - 0044
NOT_YET_RECRUITING
Rome
Japan
Local Institution - 0068
NOT_YET_RECRUITING
Bunkyo-ku
Local Institution - 0067
NOT_YET_RECRUITING
Chiba
Local Institution - 0054
NOT_YET_RECRUITING
Fukuoka
Local Institution - 0063
NOT_YET_RECRUITING
Okayama
Local Institution - 0053
NOT_YET_RECRUITING
Osaka
Local Institution - 0055
NOT_YET_RECRUITING
Sapporo
Local Institution - 0069
NOT_YET_RECRUITING
Shinjuku-ku
Local Institution - 0072
NOT_YET_RECRUITING
Yokohama
Netherlands
Local Institution - 0046
WITHDRAWN
Amsterdam
Poland
Local Institution - 0024
NOT_YET_RECRUITING
Bytom
Local Institution - 0049
NOT_YET_RECRUITING
Gliwice
Local Institution - 0034
WITHDRAWN
Lodz
Portugal
Local Institution - 0013
NOT_YET_RECRUITING
Lisbon
Spain
Local Institution - 0015
NOT_YET_RECRUITING
Barcelona
Local Institution - 0071
NOT_YET_RECRUITING
Esplugues De Llobregat
Local Institution - 0014
NOT_YET_RECRUITING
Málaga
United Kingdom
Local Institution - 0050
NOT_YET_RECRUITING
London
Local Institution - 0057
NOT_YET_RECRUITING
London
Local Institution - 0060
NOT_YET_RECRUITING
London
Local Institution - 0061
WITHDRAWN
London
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
8559073286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date: 2025-07-14
Estimated Completion Date: 2032-06-15
Participants
Target number of participants: 89
Treatments
Experimental: Administration of CC-97540
Related Therapeutic Areas
Sponsors
Leads: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company