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)
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)
2 other identifiers
interventional
89
16 countries
97
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2025
Longer than P75 for phase_2
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2025
CompletedFirst Posted
Study publicly available on registry
June 11, 2025
CompletedStudy Start
First participant enrolled
July 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 15, 2032
August 3, 2026
July 1, 2026
2.8 years
May 30, 2025
July 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission
At month 6
Secondary Outcomes (36)
Complete renal response (CRR) for participants with baseline lupus nephritis (LN)
Up to Month 60
Participants with drug-free DORIS remission
Up to month 60
CRR for participants with baseline LN
Up to month 60
Modified CRR for participants with baseline LN
Up to month 60
Number of participants achieving Lupus Low Disease Activity State (LLDAS) with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥6
Up to month 60
- +31 more secondary outcomes
Study Arms (1)
Administration of CC-97540
EXPERIMENTALInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- Participants must meet EULAR/ACR 2019 criteria for SLE.
- 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.
You may not qualify if:
- Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE.
- 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.
- 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 LDC (lymphodepleting chemotherapy) administration.
- Participant must not have inadequate organ function.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (97)
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
Colorado Blood Cancer Institute
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
Columbia University Pediatrics
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
Local Institution - 0135
Winston-Salem, North Carolina, 27106, 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
Local Institution - 0134
Paris, Île-de-France Region, 75015, 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
Rheumazentrum Ruhrgebiet
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
Ospedale Pediatrico Bambino Gesù IRCCS
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
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2025
First Posted
June 11, 2025
Study Start
July 14, 2025
Primary Completion (Estimated)
May 17, 2028
Study Completion (Estimated)
June 15, 2032
Last Updated
August 3, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- See Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html