A Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
NCT ID: NCT07015983
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
89 participants
INTERVENTIONAL
2025-07-14
2032-06-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of CC-97540
CC-97540
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Interventions
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CC-97540
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Uncontrolled or clinically significant cardiovascular conditions or CNS pathology participants must not have prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years, except for some non-invasive malignancies.
* IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant during participation in the study.
* Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, or stem cell transplant. Washout periods may be required.
* Participants must not have received live vaccines within 6 weeks before CC-97540 administration.
* Participant must not have inadequate organ function.
16 Years
ALL
No
Sponsors
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Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0009
Birmingham, Alabama, United States
Local Institution - 0080
Scottsdale, Arizona, United States
Local Institution - 0038
Los Angeles, California, United States
Local Institution - 0051
Los Angeles, California, United States
Lucile Packard Children's Hospital
Palo Alto, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Local Institution - 0002
Miami, Florida, United States
Local Institution - 0073
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
USF Health
Tampa, Florida, United States
Local Institution - 0062
Zephyrhills, Florida, United States
Local Institution - 0078
Atlanta, Georgia, United States
Local Institution - 0079
Atlanta, Georgia, United States
Local Institution - 0074
Honolulu, Hawaii, United States
Local Institution - 0052
Boston, Massachusetts, United States
Local Institution - 0011
Rochester, Minnesota, United States
Atlantic Health System Overlook Medical Center
Summit, New Jersey, United States
Hospital for Special Surgery
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Local Institution - 0005
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Local Institution - 0010
Chapel Hill, North Carolina, United States
Local Institution - 0065
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Local Institution - 0041
Oklahoma City, Oklahoma, United States
Baylor Scott and White Research Institute
Dallas, Texas, United States
Local Institution - 0007
Seattle, Washington, United States
Local Institution - 0016
ABB, Buenos Aires F.D., Argentina
Local Institution - 0017
ABB, Buenos Aires F.D., Argentina
Local Institution - 0023
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 0077
Córdoba, , Argentina
Local Institution - 0037
Vienna, Vienna, Austria
Local Institution - 0031
Salzburg, , Austria
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Local Institution - 0058
São Paulo, São Paulo, Brazil
Local Institution - 0021
São Paulo, , Brazil
Local Institution - 0022
São Paulo, , Brazil
Local Institution - 0048
Vancouver, British Columbia, Canada
Local Institution - 0045
Toronto, Ontario, Canada
Local Institution - 0056
Odense, Region Syddanmark, Denmark
Local Institution - 0047
Copenhagen, , Denmark
Local Institution - 0018
Montpellier, Hérault, France
Local Institution - 0019
Rennes, , France
Local Institution - 0081
Toulose, , France
Pitie Salpetriere University Hospital
Paris, Île-de-France Region, France
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Local Institution - 0030
Magdeburg, Saxony-Anhalt, Germany
Local Institution - 0026
Berlin, , Germany
Universitaetsklinikum Koeln
Cologne, , Germany
Local Institution - 0027
Erlangen, , Germany
Local Institution - 0043
Ramat Gan, Central District, Israel
Local Institution - 0042
Jerusalem, , Israel
Local Institution - 0025
Rome, Lazio, Italy
Local Institution - 0032
Milan, Milano, Italy
Local Institution - 0044
Rome, Roma, Italy
Local Institution - 0070
Pisa, Tuscany, Italy
Local Institution - 0055
Sapporo, Hokkaido, Japan
Local Institution - 0072
Yokohama, Kanagawa, Japan
Local Institution - 0068
Bunkyo-ku, Tokyo, Japan
Local Institution - 0069
Shinjuku-ku, Tokyo, Japan
Local Institution - 0067
Chiba, , Japan
Local Institution - 0054
Fukuoka, , Japan
Local Institution - 0063
Okayama, , Japan
Local Institution - 0053
Osaka, , Japan
Local Institution - 0046
Amsterdam, North Holland, Netherlands
Local Institution - 0024
Bytom, Silesian Voivodeship, Poland
Local Institution - 0049
Gliwice, Silesian Voivodeship, Poland
Local Institution - 0034
Lodz, Łódź Voivodeship, Poland
Local Institution - 0013
Lisbon, Lisbon District, Portugal
Local Institution - 0015
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0071
Esplugues de Llobregat, Barcelona [Barcelona], Spain
H.R.U Málaga - Hospital General
Málaga, , Spain
Local Institution - 0061
London, London, City of, United Kingdom
University College London Hospital
London, London, City of, United Kingdom
King's College Hospital
London, London, City of, United Kingdom
Local Institution - 0057
London, London, City of, United Kingdom
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 8559073286
Email: [email protected]
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Site 0009
Role: primary
Site 0080
Role: primary
Site 0038
Role: primary
Site 0051
Role: primary
Jessie Alexander, Site 0035
Role: primary
Melissa Griffith, Site 0033
Role: primary
Vikas Majithia, Site 0006
Role: primary
Site 0002
Role: primary
SAYEEF MIRZA, Site 0036
Role: primary
Loutfi Succari, Site 0008
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Site 0062
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Site 0078
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Site 0079
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Site 0052
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Neil Kramer, Site 0001
Role: primary
Kyriakos Kirou, Site 0040
Role: primary
Margrit Wiesendanger, Site 0004
Role: primary
Site 0005
Role: primary
Caitlin Gribbin, Site 0039
Role: primary
Site 0065
Role: primary
Hermine Brunner, Site 0012
Role: primary
Emily Littlejohn, Site 0003
Role: primary
Site 0041
Role: primary
Ankit Mehta, Site 0059
Role: primary
Site 0007
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Site 0016
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Site 0023
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Site 0077
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Site 0037
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Site 0031
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Ellen De Langhe, Site 0020
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Site 0058
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Site 0021
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Site 0022
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Site 0048
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Site 0045
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Site 0056
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Site 0047
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Site 0018
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Site 0019
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Site 0081
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Zahir AMOURA, Site 0064
Role: primary
Vladan Vucinic, Site 0028
Role: primary
Site 0030
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Site 0026
Role: primary
Philipp Koehler, Site 0029
Role: primary
Site 0027
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Site 0043
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Site 0042
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Site 0025
Role: primary
Site 0032
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Site 0044
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Site 0070
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Site 0055
Role: primary
Site 0072
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Site 0068
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Site 0069
Role: primary
Site 0067
Role: primary
Site 0054
Role: primary
Site 0063
Role: primary
Site 0053
Role: primary
Site 0024
Role: primary
Site 0049
Role: primary
Site 0013
Role: primary
Site 0015
Role: primary
Site 0071
Role: primary
Antonio Fernandez Nebro, Site 0014
Role: primary
Maria Leandro, Site 0060
Role: primary
Chris Wincup, Site 0050
Role: primary
Site 0057
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2024-519278-37
Identifier Type: OTHER
Identifier Source: secondary_id
CA061-1011
Identifier Type: -
Identifier Source: org_study_id