A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE)
Status: Recruiting
Location: See all (93) 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
Arizona
Local Institution - 0080
NOT_YET_RECRUITING
Scottsdale
California
Local Institution - 0038
NOT_YET_RECRUITING
Los Angeles
Local Institution - 0051
NOT_YET_RECRUITING
Los Angeles
Local Institution - 0093
NOT_YET_RECRUITING
Newport Beach
Lucile Packard Children's Hospital
RECRUITING
Palo Alto
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Washington, D.c.
Local Institution - 0097
NOT_YET_RECRUITING
Washington D.c.
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
University of Miami Hospital and Clinics, Sylvester Cancer Center
RECRUITING
Miami
Local Institution - 0073
WITHDRAWN
Orlando
Moffitt Cancer Center
RECRUITING
Tampa
USF Health
RECRUITING
Tampa
Florida Medical Clinic Orlando Health
RECRUITING
Zephyrhills
Georgia
Local Institution - 0076
NOT_YET_RECRUITING
Athens
Local Institution - 0078
NOT_YET_RECRUITING
Atlanta
Local Institution - 0079
NOT_YET_RECRUITING
Atlanta
Hawaii
Local Institution - 0074
WITHDRAWN
Honolulu
Louisiana
Local Institution - 0086
NOT_YET_RECRUITING
Baton Rouge
Massachusetts
Local Institution - 0052
NOT_YET_RECRUITING
Boston
Local Institution - 0094
NOT_YET_RECRUITING
Boston
Michigan
Local Institution - 0096
NOT_YET_RECRUITING
Ann Arbor
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WITHDRAWN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WITHDRAWN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
Hospital for Special Surgery
RECRUITING
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Local Institution - 0005
NOT_YET_RECRUITING
New York
Local Institution - 0082
NOT_YET_RECRUITING
New York
Local Institution - 0095
NOT_YET_RECRUITING
New York
Weill Cornell Medical College
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
Pennsylvania
Local Institution - 0083
NOT_YET_RECRUITING
Philadelphia
Tennessee
Local Institution - 0092
NOT_YET_RECRUITING
Memphis
Texas
Baylor Scott and White Research Institute
RECRUITING
Dallas
Washington
Swedish Medical Center
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
Uniklinikum Salzburg
RECRUITING
Salzburg
Medizinische Universität Wien
RECRUITING
Vienna
Belgium
UZ Leuven
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
Odense Universitetshospital
RECRUITING
Odense
France
CHU Montpellier Lapeyronie Hospital
RECRUITING
Montpellier
Pitie Salpetriere University Hospital
RECRUITING
Paris
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
RECRUITING
Rennes
Local Institution - 0081
NOT_YET_RECRUITING
Toulouse
Germany
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
RECRUITING
Berlin
Universitaetsklinikum Koeln
RECRUITING
Cologne
Universitaetsklinikum Erlangen
RECRUITING
Erlangen
Local Institution - 0084
NOT_YET_RECRUITING
Herne
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Universitaetsklinikum Magdeburg
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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
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
Szpital Specjalistyczny nr 1 w Bytomiu
RECRUITING
Bytom
Narodowy Instytut Onkologii - Oddzial w Gliwicach
RECRUITING
Gliwice
Local Institution - 0034
WITHDRAWN
Lodz
Portugal
Local Institution - 0013
NOT_YET_RECRUITING
Lisbon
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Local Institution - 0088
NOT_YET_RECRUITING
Donostia / San Sebastian
Hospital Sant Joan de Déu
RECRUITING
Esplugues De Llobregat
Local Institution - 0087
NOT_YET_RECRUITING
Madrid
H.R.U Málaga - Hospital General
RECRUITING
Málaga
United Kingdom
Local Institution - 0091
NOT_YET_RECRUITING
Liverpool
King's College Hospital
RECRUITING
London
Local Institution - 0057
NOT_YET_RECRUITING
London
Local Institution - 0061
WITHDRAWN
London
University College London Hospital
RECRUITING
London
Local Institution - 0090
NOT_YET_RECRUITING
Metropolitan Borough Of Wirral
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain 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