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)
Start Date
7/14/2025
Completion Date
6/15/2032
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 Criteria
Age Range: 16 years to No maximum
Interventions
CC-97540
Fludarabine
Cyclophosphamide
Conditions
Locations
Local Institution - 0106
Phoenix, Arizona 85054
United States
Local Institution - 0038
Los Angeles, California 90027
United States
Local Institution - 0051
Los Angeles, California 90095
United States
Local Institution - 0093
Newport Beach, California 92663
United States
Lucile Packard Children's Hospital
Palo Alto, California 94304
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United States
Local Institution - 0105
Denver, Colorado 80218
United States
Mayo Clinic in Florida
Jacksonville, Florida 32224
United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida 33136
United States
Local Institution - 0073
Orlando, Florida 32803
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
USF Health
Tampa, Florida 33612
United States
Florida Medical Clinic Orlando Health
Zephyrhills, Florida 33542
United States
Emory University School of Medicine
Atlanta, Georgia 30322
United States
Local Institution - 0079
Atlanta, Georgia 30322
United States
Northside Hospital
Atlanta, Georgia 30342
United States
Local Institution - 0108
Indianapolis, Indiana 46250
United States
Local Institution - 0086
Baton Rouge, Louisiana 70836
United States
Local Institution - 0110
Shreveport, Louisiana 71101
United States
Local Institution - 0094
Boston, Massachusetts 02114
United States
Local Institution - 0096
Ann Arbor, Michigan 48109
United States
Local Institution - 0011
Rochester, Minnesota 55905
United States
Atlantic Health System Overlook Medical Center
Summit, New Jersey 07901
United States
Local Institution - 0101
Manhasset, New York 11030
United States
Local Institution - 0082
New York, New York 10016
United States
Hospital for Special Surgery
New York, New York 10021
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Columbia University Irving Medical Center
New York, New York 10032
United States
Local Institution - 0095
New York, New York 10032
United States
Weill Cornell Medical College
New York, New York 10065
United States
Local Institution - 0111
Stony Brook, New York 11794
United States
Carolinas HealthCare System SouthPark
Charlotte, North Carolina 28211
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Local Institution - 0083
Philadelphia, Pennsylvania 19104
United States
Baptist Memorial Hospital
Memphis, Tennessee 38120
United States
Baylor Scott and White Research Institute
Dallas, Texas 75246
United States
Local Institution - 0098
Dallas, Texas 75390-9068
United States
Local Institution - 0104
San Antonio, Texas 78229
United States
Swedish Medical Center
Seattle, Washington 98122
United States
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D. C1199ABB
Argentina
Hospital Aleman
Buenos Aires, Buenos Aires F.D. C1118AAT
Argentina
Local Institution - 0107
Buenos Aires, B1629ODT
Argentina
Local Institution - 0077
Córdoba, X5016
Argentina
Medizinische Universität Wien
Vienna, State of Vienna 1090
Austria
Uniklinikum Salzburg
Salzburg, 5020
Austria
UZ Leuven
Leuven, Vlaams-Brabant 3000
Belgium
Local Institution - 0021
São Paulo, São Paulo 01409-001
Brazil
Local Institution - 0058
São Paulo, São Paulo 01509-010
Brazil
Local Institution - 0022
São Paulo, 05652-900
Brazil
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9
Canada
The Hospital for Sick Children
Toronto, Ontario M5G 1X8
Canada
Local Institution - 0099
Toronto, Ontario M5T 2S8
Canada
Local Institution - 0047
Copenhagen, Capital Region 2100
Denmark
Local Institution - 0132
Odense, Region Syddanmark 5000
Denmark
Odense Universitetshospital
Odense, Region Syddanmark 5000
Denmark
Local Institution - 0081
Toulouse, Haute-Garonne 31059
France
CHU Montpellier Lapeyronie Hospital
Montpellier, Hérault 34295
France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, 35033
France
Local Institution - 0109
Strasbourg, 67098
France
Pitie Salpetriere University Hospital
Paris, Île-de-France Region 75013
France
Universitätsklinikum Leipzig
Leipzig, Saxony 04103
Germany
Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt 39120
Germany
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, 10117
Germany
Universitaetsklinikum Koeln
Cologne, 50937
Germany
Universitaetsklinikum Erlangen
Erlangen, 91054
Germany
Local Institution - 0084
Herne, 44649
Germany
Sheba Medical Center
Ramat Gan, Central District 5262100
Israel
Hadassah Medical Center
Jerusalem, 9112001
Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Rome, Lazio 00168
Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano 20162
Italy
Local Institution - 0044
Rome, Roma 00165
Italy
Local Institution - 0070
Pisa, Tuscany 56126
Italy
Hokkaido University Hospital
Sapporo, Hokkaido 0608648
Japan
Yokohama City University Hospital
Yokohama, Kanagawa 236-0004
Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo 113-8431
Japan
Keio university hospital
Shinjuku-ku, Tokyo 1608582
Japan
Chiba University Hospital
Chiba, 260-8677
Japan
Kyushu University Hospital
Fukuoka, 812-8582
Japan
Okayama University Hospital
Okayama, 700-8558
Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586
Japan
Szpital Specjalistyczny nr 1 w Bytomiu
Bytom, Silesian Voivodeship 41-902
Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach
Gliwice, Silesian Voivodeship 44-101
Poland
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, Lisbon District 1649-035
Portugal
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona] 08035
Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona] 08950
Spain
Local Institution - 0088
Donostia / San Sebastian, Gipuzkoa 20014
Spain
Hospital La Princesa
Madrid, 28006
Spain
H.R.U Málaga - Hospital General
Málaga, 29011
Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
Spain
Local Institution - 0061
London, London, City of NW1 2PG
United Kingdom
University College London Hospital
London, London, City of NW1 2PG
United Kingdom
King's College Hospital
London, London, City of SE5 9RL
United Kingdom
Local Institution - 0090
Metropolitan Borough of Wirral, Merseyside L63 4JY
United Kingdom
Derriford Hospital, University Hospitals Plymouth NHS Trust
Crownhill, Plymouth, PL6 8DH
United Kingdom
Local Institution - 0091
Liverpool, L9 7AL
United Kingdom