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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)

NCT07015983 · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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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)
About this study
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
Inclusion Criteria: * 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. Exclusion Criteria: * 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 during participation in the study. * 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. * Other protocol-defined inclusion/exclusion criteria apply.
Study design
Enrollment target: 89 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2025-07-14
Estimated completion: 2032-06-15
Last updated: 2026-04-17
Interventions
Drug: CC-97540Drug: FludarabineDrug: Cyclophosphamide
Primary outcomes
  • Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission (At month 6)
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (93)
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Scottsdale, Arizona, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Denver, Colorado, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Zephyrhills, Florida, United States
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Athens, Georgia, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Cincinnati, Ohio, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Memphis, Tennessee, United States
Baylor Scott and White Research InstituteRecruiting
Dallas, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
Swedish Medical CenterRecruiting
Seattle, Washington, United States
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ABB, Buenos Aires F.D., Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Buenos Aires, Argentina
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Córdoba, Argentina
Medizinische Universität WienRecruiting
Vienna, State of Vienna, Austria
Uniklinikum SalzburgRecruiting
Salzburg, Austria
UZ LeuvenRecruiting
Leuven, Vlaams-Brabant, Belgium
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, Brazil
Vancouver General HospitalRecruiting
Vancouver, British Columbia, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
Odense UniversitetshospitalRecruiting
Odense, Region Syddanmark, Denmark
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Copenhagen, Denmark
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Toulouse, Haute-Garonne, France
CHU Montpellier Lapeyronie HospitalRecruiting
Montpellier, Hérault, France
Centre Hospitalier Universitaire de Rennes - Hôpital PontchaillouRecruiting
Rennes, France
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Strasbourg, France
Pitie Salpetriere University HospitalRecruiting
Paris, Île-de-France Region, France
Universitätsklinikum LeipzigRecruiting
Leipzig, Saxony, Germany
Universitaetsklinikum MagdeburgRecruiting
Magdeburg, Saxony-Anhalt, Germany
Charité - Universitaetsmedizin Berlin - Campus Bejnamin FranklinRecruiting
Berlin, Germany
Universitaetsklinikum KoelnRecruiting
Cologne, Germany
Universitaetsklinikum ErlangenRecruiting
Erlangen, Germany
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Herne, Germany
Sheba Medical CenterRecruiting
Ramat Gan, Central District, Israel
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Jerusalem, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro CuoreRecruiting
Rome, Lazio, Italy
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Milan, Milano, Italy
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Rome, Roma, Italy
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Pisa, Tuscany, Italy
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Sapporo, Hokkaido, Japan
Yokohama City University HospitalRecruiting
Yokohama, Kanagawa, Japan
Juntendo University HospitalRecruiting
Bunkyo-ku, Tokyo, Japan
Keio university hospitalRecruiting
Shinjuku-ku, Tokyo, Japan
Chiba University HospitalRecruiting
Chiba, Japan
Kyushu University HospitalRecruiting
Fukuoka, Japan
Okayama University HospitalRecruiting
Okayama, Japan
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Osaka, Japan
Szpital Specjalistyczny nr 1 w BytomiuRecruiting
Bytom, Silesian Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w GliwicachRecruiting
Gliwice, Silesian Voivodeship, Poland
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Lisbon, Lisbon District, Portugal
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Barcelona [Barcelona], Spain
Hospital Sant Joan de DéuRecruiting
Esplugues de Llobregat, Barcelona [Barcelona], Spain
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Donostia / San Sebastian, Gipuzkoa, Spain
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Madrid, Spain
H.R.U Málaga - Hospital GeneralRecruiting
Málaga, Spain
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Murcia, Spain
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London, London, City of, United Kingdom
University College London HospitalRecruiting
London, London, City of, United Kingdom
King's College HospitalRecruiting
London, London, City of, United Kingdom
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Metropolitan Borough of Wirral, Merseyside, United Kingdom
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Crownhill, Plymouth, United Kingdom
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Liverpool, United Kingdom
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) · TrialPath