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A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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.
Official title: 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)
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
89
Start Date
2025-07-14
Completion Date
2032-06-15
Last Updated
2026-04-07
Healthy Volunteers
No
Interventions
CC-97540
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Locations (104)
Local Institution - 0009
Birmingham, Alabama, United States
Local Institution - 0080
Scottsdale, Arizona, United States
Local Institution - 0106
Scottsdale, Arizona, United States
Local Institution - 0038
Los Angeles, California, United States
Local Institution - 0051
Los Angeles, California, United States
Local Institution - 0093
Newport Beach, California, United States
Lucile Packard Children's Hospital
Palo Alto, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Local Institution - 0105
Denver, Colorado, United States
Local Institution - 0097
Washington D.C., District of Columbia, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States
Local Institution - 0073
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
USF Health
Tampa, Florida, United States
Florida Medical Clinic Orlando Health
Zephyrhills, Florida, United States
Local Institution - 0076
Athens, Georgia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Local Institution - 0079
Atlanta, Georgia, United States
Local Institution - 0074
Honolulu, Hawaii, United States
Local Institution - 0108
Indianapolis, Indiana, United States
Local Institution - 0086
Baton Rouge, Louisiana, United States
Local Institution - 0094
Boston, Massachusetts, United States
Local Institution - 0052
Boston, Massachusetts, United States
Local Institution - 0096
Ann Arbor, Michigan, United States
Local Institution - 0011
Rochester, Minnesota, United States
Atlantic Health System Overlook Medical Center
Summit, New Jersey, United States
Local Institution - 0101
Manhasset, New York, United States
Local Institution - 0082
New York, New York, 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
Columbia University Irving Medical Center
New York, New York, United States
Local Institution - 0095
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
Local Institution - 0083
Philadelphia, Pennsylvania, United States
Local Institution - 0092
Memphis, Tennessee, United States
Baylor Scott and White Research Institute
Dallas, Texas, United States
Local Institution - 0098
Dallas, Texas, United States
Local Institution - 0104
San Antonio, Texas, United States
Swedish Medical Center
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 - 0107
Buenos Aires, Argentina
Local Institution - 0077
Córdoba, Argentina
Medizinische Universität Wien
Vienna, Vienna, Austria
Uniklinikum Salzburg
Salzburg, Austria
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Local Institution - 0021
São Paulo, São Paulo, Brazil
Local Institution - 0058
São Paulo, São Paulo, Brazil
Local Institution - 0022
São Paulo, Brazil
Local Institution - 0048
Vancouver, British Columbia, Canada
Local Institution - 0045
Toronto, Ontario, Canada
Local Institution - 0099
Toronto, Ontario, Canada
Odense Universitetshospital
Odense, Region Syddanmark, Denmark
Local Institution - 0047
Copenhagen, Denmark
Local Institution - 0081
Toulouse, Haute-Garonne, France
CHU Montpellier Lapeyronie Hospital
Montpellier, Hérault, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, France
Local Institution - 0109
Strasbourg, France
Pitie Salpetriere University Hospital
Paris, Île-de-France Region, France
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt, Germany
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, Germany
Universitaetsklinikum Koeln
Cologne, Germany
Universitaetsklinikum Erlangen
Erlangen, Germany
Local Institution - 0084
Herne, Germany
Sheba Medical Center
Ramat Gan, Central District, Israel
Local Institution - 0042
Jerusalem, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
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
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Keio university hospital
Shinjuku-ku, Tokyo, Japan
Chiba University Hospital
Chiba, Japan
Kyushu University Hospital
Fukuoka, Japan
Okayama University Hospital
Okayama, Japan
Local Institution - 0053
Osaka, Japan
Local Institution - 0046
Amsterdam, North Holland, Netherlands
Szpital Specjalistyczny nr 1 w Bytomiu
Bytom, Silesian Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach
Gliwice, Silesian Voivodeship, Poland
Local Institution - 0034
Lodz, Łódź Voivodeship, Poland
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, Lisbon District, Portugal
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], Spain
Local Institution - 0088
Donostia / San Sebastian, Gipuzkoa, Spain
Local Institution - 0087
Madrid, Spain
H.R.U Málaga - Hospital General
Málaga, Spain
Local Institution - 0089
Murcia, 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
Local Institution - 0090
Metropolitan Borough of Wirral, Merseyside, United Kingdom
Local Institution - 0102
Crownhill, Plymouth, United Kingdom
Local Institution - 0091
Liverpool, United Kingdom