Actively Recruiting
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)
Led by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Updated on 2026-05-08
89
Participants Needed
93
Research Sites
361 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must meet EULAR/ACR 2019 criteria for SLE.
- Participants must have an inadequate response to appropriate doses of glucocorticoids and 252 immunosuppressant therapies, used for at least 3 months.
- Participants must have active disease when signing informed consent form.
You will not qualify if you...
- Participants must not have other diseases, conditions, or treatments that may affect interpretation of CC-97540 effects.
- Participants must not have uncontrolled or significant cardiovascular conditions or CNS pathology.
- Participants must not have prior history of malignancies or lymphoproliferative disease unless disease-free for at least 2 years, except some non-invasive malignancies.
- Women who are pregnant, nursing, breastfeeding, or intend to become pregnant are excluded.
- Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, stem cell transplant, or organ transplant.
- Participants must not have received live vaccines within 6 weeks before lymphodepleting chemotherapy administration.
- Participant must not have inadequate organ function.
- Other protocol-defined inclusion/exclusion criteria apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 93 locations
1
Local Institution - 0106
Scottsdale, Arizona, United States, 85259
Not Yet Recruiting
2
Local Institution - 0038
Los Angeles, California, United States, 90027
Not Yet Recruiting
3
Local Institution - 0051
Los Angeles, California, United States, 90095
Not Yet Recruiting
4
Local Institution - 0093
Newport Beach, California, United States, 92658
Not Yet Recruiting
5
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
Actively Recruiting
6
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Local Institution - 0105
Denver, Colorado, United States, 80218
Not Yet Recruiting
8
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
9
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
10
Local Institution - 0073
Orlando, Florida, United States, 32803
Not Yet Recruiting
11
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
12
USF Health
Tampa, Florida, United States, 33612
Actively Recruiting
13
Florida Medical Clinic Orlando Health
Zephyrhills, Florida, United States, 33542
Actively Recruiting
14
Local Institution - 0076
Athens, Georgia, United States, 30606
Not Yet Recruiting
15
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
16
Local Institution - 0079
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
17
Local Institution - 0108
Indianapolis, Indiana, United States, 46250
Not Yet Recruiting
18
Local Institution - 0086
Baton Rouge, Louisiana, United States, 70836
Not Yet Recruiting
19
Local Institution - 0094
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
20
Local Institution - 0096
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
21
Local Institution - 0011
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
22
Atlantic Health System Overlook Medical Center
Summit, New Jersey, United States, 07901
Actively Recruiting
23
Local Institution - 0101
Manhasset, New York, United States, 11030
Not Yet Recruiting
24
Local Institution - 0082
New York, New York, United States, 10016
Not Yet Recruiting
25
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
26
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
27
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
28
Local Institution - 0095
New York, New York, United States, 10032
Not Yet Recruiting
29
Weill Cornell Medical College
New York, New York, United States, 10065
Actively Recruiting
30
Carolinas HealthCare System SouthPark
Charlotte, North Carolina, United States, 28211
Actively Recruiting
31
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
32
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
33
Local Institution - 0083
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
34
Local Institution - 0092
Memphis, Tennessee, United States, 38120
Not Yet Recruiting
35
Baylor Scott and White Research Institute
Dallas, Texas, United States, 75246
Actively Recruiting
36
Local Institution - 0098
Dallas, Texas, United States, 75390-9068
Not Yet Recruiting
37
Local Institution - 0104
San Antonio, Texas, United States, 78229
Not Yet Recruiting
38
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
39
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., Argentina, C1199ABB
Actively Recruiting
40
Local Institution - 0023
Buenos Aires, Buenos Aires F.D., Argentina, C1118AAT
Not Yet Recruiting
41
Local Institution - 0107
Buenos Aires, Argentina, B1629ODT
Not Yet Recruiting
42
Local Institution - 0077
Córdoba, Argentina, X5016
Not Yet Recruiting
43
Medizinische Universität Wien
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
44
Uniklinikum Salzburg
Salzburg, Austria, 5020
Actively Recruiting
45
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
46
Local Institution - 0021
São Paulo, São Paulo, Brazil, 01409-001
Not Yet Recruiting
47
Local Institution - 0058
São Paulo, São Paulo, Brazil, 01509-010
Not Yet Recruiting
48
Local Institution - 0022
São Paulo, Brazil, 05652-900
Not Yet Recruiting
49
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
50
Local Institution - 0045
Toronto, Ontario, Canada, M5G 1X8
Not Yet Recruiting
51
Local Institution - 0099
Toronto, Ontario, Canada, M5T 2S8
Not Yet Recruiting
52
Odense Universitetshospital
Odense, Region Syddanmark, Denmark, 5000
Actively Recruiting
53
Local Institution - 0047
Copenhagen, Denmark, 2100
Not Yet Recruiting
54
Local Institution - 0081
Toulouse, Haute-Garonne, France, 31059
Not Yet Recruiting
55
CHU Montpellier Lapeyronie Hospital
Montpellier, Hérault, France, 34295
Actively Recruiting
56
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, France, 35033
Actively Recruiting
57
Local Institution - 0109
Strasbourg, France, 67098
Not Yet Recruiting
58
Pitie Salpetriere University Hospital
Paris, Île-de-France Region, France, 75013
Actively Recruiting
59
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
60
Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt, Germany, 39120
Actively Recruiting
61
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, Germany, 10117
Actively Recruiting
62
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Actively Recruiting
63
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
64
Local Institution - 0084
Herne, Germany, 44649
Not Yet Recruiting
65
Sheba Medical Center
Ramat Gan, Central District, Israel, 5262100
Actively Recruiting
66
Local Institution - 0042
Jerusalem, Israel, 9112001
Not Yet Recruiting
67
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Rome, Lazio, Italy, 00168
Actively Recruiting
68
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, Italy, 20162
Actively Recruiting
69
Local Institution - 0044
Rome, Roma, Italy, 00165
Not Yet Recruiting
70
Local Institution - 0070
Pisa, Tuscany, Italy, 56126
Not Yet Recruiting
71
Local Institution - 0055
Sapporo, Hokkaido, Japan, 0608648
Not Yet Recruiting
72
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Actively Recruiting
73
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Actively Recruiting
74
Keio university hospital
Shinjuku-ku, Tokyo, Japan, 1608582
Actively Recruiting
75
Chiba University Hospital
Chiba, Japan, 260-8677
Actively Recruiting
76
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Actively Recruiting
77
Okayama University Hospital
Okayama, Japan, 700-8558
Actively Recruiting
78
Osaka Metropolitan University Hospital
Osaka, Japan, 545-8586
Actively Recruiting
79
Szpital Specjalistyczny nr 1 w Bytomiu
Bytom, Silesian Voivodeship, Poland, 41-902
Actively Recruiting
80
Narodowy Instytut Onkologii - Oddzial w Gliwicach
Gliwice, Silesian Voivodeship, Poland, 44-101
Actively Recruiting
81
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, Lisbon District, Portugal, 1649-035
Actively Recruiting
82
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
83
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
Actively Recruiting
84
Local Institution - 0088
Donostia / San Sebastian, Gipuzkoa, Spain, 20014
Not Yet Recruiting
85
Local Institution - 0087
Madrid, Spain, 28006
Not Yet Recruiting
86
H.R.U Málaga - Hospital General
Málaga, Spain, 29011
Actively Recruiting
87
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Actively Recruiting
88
Local Institution - 0061
London, London, City of, United Kingdom, NW1 2PG
Withdrawn
89
University College London Hospital
London, London, City of, United Kingdom, NW1 2PG
Actively Recruiting
90
King's College Hospital
London, London, City of, United Kingdom, SE5 9RL
Actively Recruiting
91
Local Institution - 0090
Metropolitan Borough of Wirral, Merseyside, United Kingdom, L63 4JY
Not Yet Recruiting
92
Local Institution - 0102
Crownhill, Plymouth, United Kingdom, PL6 8DH
Not Yet Recruiting
93
Local Institution - 0091
Liverpool, United Kingdom, L9 7AL
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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