Actively Recruiting
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)
Led by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Updated on 2026-06-01
89
Participants Needed
95
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug CC-97540 in people aged 16 and older who have active systemic lupus erythematosus (SLE), including lupus nephritis, and who have not responded well to glucocorticoids and at least two immunosuppressant treatments. This Phase 2 study aims to assess the effectiveness, safety, and drug levels of CC-97540 in this group. The study is sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. Participants will receive CC-97540, a type of CD19-targeted NEX-T CAR T cell therapy, along with specified doses of fludarabine and cyclophosphamide on scheduled days. The study is open-label and multicenter, meaning both participants and researchers know which treatment is given. The treatments are designed to evaluate disease control and remission in participants with inadequate prior responses. The study includes multiple assessments over a period of up to 60 months to monitor various health outcomes. Throughout the study, participants will be closely monitored with regular assessments, including measuring drug-free remission rates, kidney response in lupus nephritis cases, disease activity, and patient-reported outcomes like fatigue and pain. Laboratory tests will track kidney function, autoantibody levels, and immune system markers. Safety is carefully observed by recording adverse events and lab abnormalities. The total participation duration can last up to 60 months, allowing thorough evaluation of long-term effects and disease status.
CONDITIONS
Brief 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 systemic lupus erythematosus (SLE).
- Participants must have an inadequate response to appropriate doses of glucocorticoids and at least 2 immunosuppressant therapies, used for at least 3 months.
- Participants must have active disease at the time of consent.
You will not qualify if you...
- Participants with other diseases, conditions, or treatments that could affect study results.
- Participants with uncontrolled or significant cardiovascular or central nervous system conditions.
- Participants with a history of malignancies or lymphoproliferative disease unless disease-free for at least 2 years, except certain non-invasive cancers.
- Pregnant or breastfeeding individuals, or those planning pregnancy.
- Participants with prior CAR T cell therapy, genetically modified T cell therapy, stem cell transplant, or organ transplant.
- Participants who received live vaccines within 6 weeks before lymphodepleting chemotherapy.
- Participants with inadequate organ function.
- Other protocol-defined criteria may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Specified dosing days during the treatment period
Participants receive specified doses of CC-97540, Fludarabine, and Cyclophosphamide on specified days as part of the treatment for active SLE.
1 baseline visit and multiple treatment visits as per protocol
Duration - Up to 60 months
Participants are monitored for up to 60 months to assess remission status, kidney response, disease activity, and safety outcomes.
Regular follow-up visits over 5 years
Trial Site Locations
Total: 95 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, 92663
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
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
15
Local Institution - 0079
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
16
Northside Hospital
Atlanta, Georgia, United States, 30342
Actively 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 - 0110
Shreveport, Louisiana, United States, 71101
Not Yet Recruiting
20
Local Institution - 0094
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
21
Local Institution - 0096
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
22
Local Institution - 0011
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
23
Atlantic Health System Overlook Medical Center
Summit, New Jersey, United States, 07901
Actively Recruiting
24
Local Institution - 0101
Manhasset, New York, United States, 11030
Not Yet Recruiting
25
Local Institution - 0082
New York, New York, United States, 10016
Not Yet Recruiting
26
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
27
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
28
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
29
Local Institution - 0095
New York, New York, United States, 10032
Not Yet Recruiting
30
Weill Cornell Medical College
New York, New York, United States, 10065
Actively Recruiting
31
Local Institution - 0111
Stony Brook, New York, United States, 11794
Not Yet Recruiting
32
Carolinas HealthCare System SouthPark
Charlotte, North Carolina, United States, 28211
Actively Recruiting
33
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
34
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
35
Local Institution - 0083
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
36
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
Actively Recruiting
37
Baylor Scott and White Research Institute
Dallas, Texas, United States, 75246
Actively Recruiting
38
Local Institution - 0098
Dallas, Texas, United States, 75390-9068
Not Yet Recruiting
39
Local Institution - 0104
San Antonio, Texas, United States, 78229
Not Yet Recruiting
40
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
41
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., Argentina, C1199ABB
Actively Recruiting
42
Hospital Aleman
Buenos Aires, Buenos Aires F.D., Argentina, C1118AAT
Actively Recruiting
43
Local Institution - 0107
Buenos Aires, Argentina, B1629ODT
Not Yet Recruiting
44
Local Institution - 0077
Córdoba, Argentina, X5016
Not Yet Recruiting
45
Medizinische Universität Wien
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
46
Uniklinikum Salzburg
Salzburg, Austria, 5020
Actively Recruiting
47
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
48
Local Institution - 0021
São Paulo, São Paulo, Brazil, 01409-001
Not Yet Recruiting
49
Local Institution - 0058
São Paulo, São Paulo, Brazil, 01509-010
Not Yet Recruiting
50
Local Institution - 0022
São Paulo, Brazil, 05652-900
Not Yet Recruiting
51
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
52
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
53
Local Institution - 0099
Toronto, Ontario, Canada, M5T 2S8
Not Yet Recruiting
54
Local Institution - 0047
Copenhagen, Capital Region, Denmark, 2100
Not Yet Recruiting
55
Odense Universitetshospital
Odense, Region Syddanmark, Denmark, 5000
Actively Recruiting
56
Local Institution - 0081
Toulouse, Haute-Garonne, France, 31059
Not Yet Recruiting
57
CHU Montpellier Lapeyronie Hospital
Montpellier, Hérault, France, 34295
Actively Recruiting
58
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, France, 35033
Actively Recruiting
59
Local Institution - 0109
Strasbourg, France, 67098
Not Yet Recruiting
60
Pitie Salpetriere University Hospital
Paris, Île-de-France Region, France, 75013
Actively Recruiting
61
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
62
Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt, Germany, 39120
Actively Recruiting
63
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, Germany, 10117
Actively Recruiting
64
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Actively Recruiting
65
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
66
Local Institution - 0084
Herne, Germany, 44649
Not Yet Recruiting
67
Sheba Medical Center
Ramat Gan, Central District, Israel, 5262100
Actively Recruiting
68
Local Institution - 0042
Jerusalem, Israel, 9112001
Not Yet Recruiting
69
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Rome, Lazio, Italy, 00168
Actively Recruiting
70
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, Italy, 20162
Actively Recruiting
71
Local Institution - 0044
Rome, Roma, Italy, 00165
Not Yet Recruiting
72
Local Institution - 0070
Pisa, Tuscany, Italy, 56126
Not Yet Recruiting
73
Local Institution - 0055
Sapporo, Hokkaido, Japan, 0608648
Not Yet Recruiting
74
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Actively Recruiting
75
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Actively Recruiting
76
Keio university hospital
Shinjuku-ku, Tokyo, Japan, 1608582
Actively Recruiting
77
Chiba University Hospital
Chiba, Japan, 260-8677
Actively Recruiting
78
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Actively Recruiting
79
Okayama University Hospital
Okayama, Japan, 700-8558
Actively Recruiting
80
Osaka Metropolitan University Hospital
Osaka, Japan, 545-8586
Actively Recruiting
81
Szpital Specjalistyczny nr 1 w Bytomiu
Bytom, Silesian Voivodeship, Poland, 41-902
Actively Recruiting
82
Narodowy Instytut Onkologii - Oddzial w Gliwicach
Gliwice, Silesian Voivodeship, Poland, 44-101
Actively Recruiting
83
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, Lisbon District, Portugal, 1649-035
Actively Recruiting
84
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
85
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
Actively Recruiting
86
Local Institution - 0088
Donostia / San Sebastian, Gipuzkoa, Spain, 20014
Not Yet Recruiting
87
Hospital La Princesa
Madrid, Spain, 28006
Actively Recruiting
88
H.R.U Málaga - Hospital General
Málaga, Spain, 29011
Actively Recruiting
89
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Actively Recruiting
90
Local Institution - 0061
London, London, City of, United Kingdom, NW1 2PG
Withdrawn
91
University College London Hospital
London, London, City of, United Kingdom, NW1 2PG
Actively Recruiting
92
King's College Hospital
London, London, City of, United Kingdom, SE5 9RL
Actively Recruiting
93
Local Institution - 0090
Metropolitan Borough of Wirral, Merseyside, United Kingdom, L63 4JY
Not Yet Recruiting
94
Derriford Hospital, University Hospitals Plymouth NHS Trust
Crownhill, Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
95
Local Institution - 0091
Liverpool, United Kingdom, L9 7AL
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
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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