--- 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) nct_id: NCT07015983 overall_status: RECRUITING phase: PHASE2 sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company study_type: INTERVENTIONAL primary_condition: Lupus Erythematosus, Systemic countries: United States, Argentina, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Israel, Italy, Japan, Poland, Portugal, Spain, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07015983.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07015983" ct_last_update_post_date: 2026-05-08 last_seen_at: "2026-05-12T06:19:57.285Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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) **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) **NCT ID:** [NCT07015983](https://clinicaltrials.gov/study/NCT07015983) ## Key Facts - **Status:** RECRUITING - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 89 - **Lead Sponsor:** Juno Therapeutics, Inc., a Bristol-Myers Squibb Company - **Conditions:** Lupus Erythematosus, Systemic, Lupus Nephritis - **Start Date:** 2025-07-14 - **Completion Date:** 2032-06-15 - **CT.gov Last Update:** 2026-05-08 ## 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. ## Eligibility - **Minimum age:** 16 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. * 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. ``` ## Arms - **Administration of CC-97540** (EXPERIMENTAL) ## Interventions - **CC-97540** (DRUG) — Specified dose on specified days - **Fludarabine** (DRUG) — Specified dose on specified days - **Cyclophosphamide** (DRUG) — Specified dose on specified days ## Primary Outcomes - **Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission** _(time frame: At month 6)_ ## Secondary Outcomes - **Complete renal response (CRR) for participants with baseline lupus nephritis (LN)** _(time frame: Up to Month 60)_ - **Participants with drug-free DORIS remission** _(time frame: Up to month 60)_ - **CRR for participants with baseline LN** _(time frame: Up to month 60)_ - **Modified CRR for participants with baseline LN** _(time frame: Up to month 60)_ - **Number of participants achieving Lupus Low Disease Activity State (LLDAS) with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥6** _(time frame: Up to month 60)_ - **Number of participants achieving SLE Responder Index (SRI) - 4 with baseline SLEDAI ≥6** _(time frame: Up to month 60)_ - **Number of participants with flares as assessed by SLEDAI flare index** _(time frame: Up to month 60)_ - **Severity of participants with flares as assessed by SLEDAI flare index** _(time frame: Up to month 60)_ - **Change from baseline in proteinuria** _(time frame: Up to month 60)_ - **Change from baseline in estimated glomerular filtration rate (eGFR)** _(time frame: Up to month 60)_ - **Change from baseline in Systemic Lupus International Collaborating Clinics (SLICC)/ACR (American College of Rheumatology) damage index** _(time frame: Up to month 60)_ - **Percentage of participants achieving maintenance of drug-free DORIS remission** _(time frame: Up to month 60)_ - **Percentage of participants achieving maintenance of LLDAS** _(time frame: Up to month 60)_ - **Percentage of participants achieving maintenance of SRI-4** _(time frame: Up to month 60)_ - **Time from first response to loss of response for drug-free DORIS remission** _(time frame: Up to month 60)_ - **Time from first response to loss of response for LLDAS** _(time frame: Up to month 60)_ - **Time from first response to loss of response for SRI-4** _(time frame: Up to month 60)_ - **Time from baseline to first drug-free DORIS remission** _(time frame: Up to month 60)_ - **Time from baseline to LLDAS** _(time frame: Up to month 60)_ - **Time from baseline to SRI-4** _(time frame: Up to month 60)_ - **Duration of drug-free status** _(time frame: Up to month 60)_ - **Percentage of participants achieving DORIS remission regardless of drug-free status** _(time frame: Up to month 60)_ - **Glucocorticoid used post-infusion for SLE treatment** _(time frame: Up to month 60)_ - **Change of serum autoantibodies from baseline** _(time frame: Up to month 60)_ - **Change in complement factor (C3 and C4) levels from baseline** _(time frame: Up to month 60)_ - **Change from baseline in patient reported outcomes (PRO) as assessed by FACIT-Fatigue** _(time frame: Up to month 60)_ - **Change from baseline in PRO as assessed by SF 36 v2 Acute** _(time frame: Up to month 60)_ - **Change from baseline in PRO as assessed by EQ-5D-5L** _(time frame: Up to month 60)_ - **Change from baseline in PRO as assessed by Patient Global Impression of Severity (PGI-S) Pain** _(time frame: Up to month 60)_ - **Change from baseline in PRO as assessed by PGI-S Fatigue** _(time frame: Up to month 60)_ - **Patient Global Impression of Change (PGI-C) Pain** _(time frame: Up to month 60)_ - **PGI-C Fatigue** _(time frame: Up to month 60)_ - **Number of participants with Adverse Events (AEs)** _(time frame: Up to month 60)_ - **Number of participants with serious AEs (SAEs)** _(time frame: Up to month 60)_ - **Number of participants with AESIs (AEs of Special Interest)** _(time frame: Up to month 60)_ - **Number of participants with clinically significant laboratory abnormalities** _(time frame: Up to month 60)_ ## Locations (93) - Local Institution - 0106, Scottsdale, Arizona, United States — _NOT_YET_RECRUITING_ - Local Institution - 0038, Los Angeles, California, United States — _NOT_YET_RECRUITING_ - Local Institution - 0051, Los Angeles, California, United States — _NOT_YET_RECRUITING_ - Local Institution - 0093, Newport Beach, California, United States — _NOT_YET_RECRUITING_ - Lucile Packard Children's Hospital, Palo Alto, California, United States — _RECRUITING_ - University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States — _RECRUITING_ - Local Institution - 0105, Denver, Colorado, United States — _NOT_YET_RECRUITING_ - Mayo Clinic in Florida, Jacksonville, Florida, United States — _RECRUITING_ - University of Miami Hospital and Clinics, Sylvester Cancer Center, Miami, Florida, United States — _RECRUITING_ - Local Institution - 0073, Orlando, Florida, United States — _NOT_YET_RECRUITING_ - Moffitt Cancer Center, Tampa, Florida, United States — _RECRUITING_ - USF Health, Tampa, Florida, United States — _RECRUITING_ - Florida Medical Clinic Orlando Health, Zephyrhills, Florida, United States — _RECRUITING_ - Local Institution - 0076, Athens, Georgia, United States — _NOT_YET_RECRUITING_ - Emory University School of Medicine, Atlanta, Georgia, United States — _RECRUITING_ - Local Institution - 0079, Atlanta, Georgia, United States — _NOT_YET_RECRUITING_ - Local Institution - 0108, Indianapolis, Indiana, United States — _NOT_YET_RECRUITING_ - Local Institution - 0086, Baton Rouge, Louisiana, United States — _NOT_YET_RECRUITING_ - Local Institution - 0094, Boston, Massachusetts, United States — _NOT_YET_RECRUITING_ - Local Institution - 0096, Ann Arbor, Michigan, United States — _NOT_YET_RECRUITING_ - Local Institution - 0011, Rochester, Minnesota, United States — _NOT_YET_RECRUITING_ - Atlantic Health System Overlook Medical Center, Summit, New Jersey, United States — _RECRUITING_ - Local Institution - 0101, Manhasset, New York, United States — _NOT_YET_RECRUITING_ - Local Institution - 0082, New York, New York, United States — _NOT_YET_RECRUITING_ - Hospital for Special Surgery, New York, New York, United States — _RECRUITING_ - Icahn School of Medicine at Mount Sinai, New York, New York, United States — _RECRUITING_ - Columbia University Irving Medical Center, New York, New York, United States — _RECRUITING_ - Local Institution - 0095, New York, New York, United States — _NOT_YET_RECRUITING_ - Weill Cornell Medical College, New York, New York, United States — _RECRUITING_ - Carolinas HealthCare System SouthPark, Charlotte, North Carolina, United States — _RECRUITING_ - Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States — _RECRUITING_ - Cleveland Clinic, Cleveland, Ohio, United States — _RECRUITING_ - Local Institution - 0083, Philadelphia, Pennsylvania, United States — _NOT_YET_RECRUITING_ - Local Institution - 0092, Memphis, Tennessee, United States — _NOT_YET_RECRUITING_ - Baylor Scott and White Research Institute, Dallas, Texas, United States — _RECRUITING_ - Local Institution - 0098, Dallas, Texas, United States — _NOT_YET_RECRUITING_ - Local Institution - 0104, San Antonio, Texas, United States — _NOT_YET_RECRUITING_ - Swedish Medical Center, Seattle, Washington, United States — _RECRUITING_ - Hospital Italiano de Buenos Aires, ABB, Buenos Aires F.D., Argentina — _RECRUITING_ - Local Institution - 0023, Buenos Aires, Buenos Aires F.D., Argentina — _NOT_YET_RECRUITING_ - Local Institution - 0107, Buenos Aires, Argentina — _NOT_YET_RECRUITING_ - Local Institution - 0077, Córdoba, Argentina — _NOT_YET_RECRUITING_ - Medizinische Universität Wien, Vienna, State of Vienna, Austria — _RECRUITING_ - Uniklinikum Salzburg, Salzburg, Austria — _RECRUITING_ - UZ Leuven, Leuven, Vlaams-Brabant, Belgium — _RECRUITING_ - Local Institution - 0021, São Paulo, São Paulo, Brazil — _NOT_YET_RECRUITING_ - Local Institution - 0058, São Paulo, São Paulo, Brazil — _NOT_YET_RECRUITING_ - Local Institution - 0022, São Paulo, Brazil — _NOT_YET_RECRUITING_ - Vancouver General Hospital, Vancouver, British Columbia, Canada — _RECRUITING_ - Local Institution - 0045, Toronto, Ontario, Canada — _NOT_YET_RECRUITING_ - Local Institution - 0099, Toronto, Ontario, Canada — _NOT_YET_RECRUITING_ - Odense Universitetshospital, Odense, Region Syddanmark, Denmark — _RECRUITING_ - Local Institution - 0047, Copenhagen, Denmark — _NOT_YET_RECRUITING_ - Local Institution - 0081, Toulouse, Haute-Garonne, France — _NOT_YET_RECRUITING_ - CHU Montpellier Lapeyronie Hospital, Montpellier, Hérault, France — _RECRUITING_ - Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou, Rennes, France — _RECRUITING_ - Local Institution - 0109, Strasbourg, France — _NOT_YET_RECRUITING_ - Pitie Salpetriere University Hospital, Paris, Île-de-France Region, France — _RECRUITING_ - Universitätsklinikum Leipzig, Leipzig, Saxony, Germany — _RECRUITING_ - Universitaetsklinikum Magdeburg, Magdeburg, Saxony-Anhalt, Germany — _RECRUITING_ - Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin, Berlin, Germany — _RECRUITING_ - Universitaetsklinikum Koeln, Cologne, Germany — _RECRUITING_ - Universitaetsklinikum Erlangen, Erlangen, Germany — _RECRUITING_ - Local Institution - 0084, Herne, Germany — _NOT_YET_RECRUITING_ - Sheba Medical Center, Ramat Gan, Central District, Israel — _RECRUITING_ - Local Institution - 0042, Jerusalem, Israel — _NOT_YET_RECRUITING_ - Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore, Rome, Lazio, Italy — _RECRUITING_ - ASST Grande Ospedale Metropolitano Niguarda, Milan, Milano, Italy — _RECRUITING_ - Local Institution - 0044, Rome, Roma, Italy — _NOT_YET_RECRUITING_ - Local Institution - 0070, Pisa, Tuscany, Italy — _NOT_YET_RECRUITING_ - Local Institution - 0055, Sapporo, Hokkaido, Japan — _NOT_YET_RECRUITING_ - Yokohama City University Hospital, Yokohama, Kanagawa, Japan — _RECRUITING_ - Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan — _RECRUITING_ - Keio university hospital, Shinjuku-ku, Tokyo, Japan — _RECRUITING_ - Chiba University Hospital, Chiba, Japan — _RECRUITING_ - Kyushu University Hospital, Fukuoka, Japan — _RECRUITING_ - Okayama University Hospital, Okayama, Japan — _RECRUITING_ - Osaka Metropolitan University Hospital, Osaka, Japan — _RECRUITING_ - Szpital Specjalistyczny nr 1 w Bytomiu, Bytom, Silesian Voivodeship, Poland — _RECRUITING_ - Narodowy Instytut Onkologii - Oddzial w Gliwicach, Gliwice, Silesian Voivodeship, Poland — _RECRUITING_ - Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisbon, Lisbon District, Portugal — _RECRUITING_ - Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], Spain — _RECRUITING_ - Hospital Sant Joan de Déu, Esplugues de Llobregat, Barcelona [Barcelona], Spain — _RECRUITING_ - Local Institution - 0088, Donostia / San Sebastian, Gipuzkoa, Spain — _NOT_YET_RECRUITING_ - Local Institution - 0087, Madrid, Spain — _NOT_YET_RECRUITING_ - H.R.U Málaga - Hospital General, Málaga, Spain — _RECRUITING_ - Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain — _RECRUITING_ - Local Institution - 0061, London, London, City of, United Kingdom — _WITHDRAWN_ - University College London Hospital, London, London, City of, United Kingdom — _RECRUITING_ - King's College Hospital, London, London, City of, United Kingdom — _RECRUITING_ - Local Institution - 0090, Metropolitan Borough of Wirral, Merseyside, United Kingdom — _NOT_YET_RECRUITING_ - Local Institution - 0102, Crownhill, Plymouth, United Kingdom — _NOT_YET_RECRUITING_ - Local Institution - 0091, Liverpool, United Kingdom — _NOT_YET_RECRUITING_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.local institution - 0106|scottsdale|arizona|united states` — added _(2026-05-12)_ - `locations.local institution - 0038|los angeles|california|united states` — added _(2026-05-12)_ - `locations.local institution - 0051|los angeles|california|united states` — added _(2026-05-12)_ - `locations.local institution - 0093|newport beach|california|united states` — added _(2026-05-12)_ - `locations.lucile packard children's hospital|palo alto|california|united states` — added _(2026-05-12)_ - `locations.university of colorado anschutz medical campus|aurora|colorado|united states` — added _(2026-05-12)_ - `locations.local institution - 0105|denver|colorado|united states` — added _(2026-05-12)_ - `locations.mayo clinic in florida|jacksonville|florida|united states` — added _(2026-05-12)_ - `locations.university of miami hospital and clinics, sylvester cancer center|miami|florida|united states` — added _(2026-05-12)_ - `locations.local institution - 0073|orlando|florida|united states` — added _(2026-05-12)_ - `locations.moffitt cancer center|tampa|florida|united states` — added _(2026-05-12)_ - `locations.usf health|tampa|florida|united states` — added _(2026-05-12)_ - `locations.florida medical clinic orlando health|zephyrhills|florida|united states` — added _(2026-05-12)_ - `locations.local institution - 0076|athens|georgia|united states` — added _(2026-05-12)_ - `locations.emory university school of medicine|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.local institution - 0079|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.local institution - 0108|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.local institution - 0086|baton rouge|louisiana|united states` — added _(2026-05-12)_ - `locations.local institution - 0094|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.local institution - 0096|ann arbor|michigan|united states` — added _(2026-05-12)_ - `locations.local institution - 0011|rochester|minnesota|united states` — added _(2026-05-12)_ - `locations.atlantic health system overlook medical center|summit|new jersey|united states` — added _(2026-05-12)_ - `locations.local institution - 0101|manhasset|new york|united states` — added _(2026-05-12)_ - `locations.local institution - 0082|new york|new york|united states` — added _(2026-05-12)_ - `locations.hospital for special surgery|new york|new york|united states` — added _(2026-05-12)_ - `locations.icahn school of medicine at mount sinai|new york|new york|united states` — added _(2026-05-12)_ - `locations.columbia university irving medical center|new york|new york|united states` — added _(2026-05-12)_ - `locations.local institution - 0095|new york|new york|united states` — added _(2026-05-12)_ - `locations.weill cornell medical college|new york|new york|united states` — added _(2026-05-12)_ - `locations.carolinas healthcare system southpark|charlotte|north carolina|united states` — added _(2026-05-12)_ - `locations.cincinnati children's hospital medical center|cincinnati|ohio|united states` — added _(2026-05-12)_ - `locations.cleveland clinic|cleveland|ohio|united states` — added _(2026-05-12)_ - `locations.local institution - 0083|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ - `locations.local institution - 0092|memphis|tennessee|united states` — added _(2026-05-12)_ - `locations.baylor scott and white research institute|dallas|texas|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07015983.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07015983* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*