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 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CA061-10112024-519278-37
• Study Type: interventional
• Target: 89
• Locations: 16 countries
• Sites: 93

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.

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis

Keywords

Lupus; SLE; LN; CAR T; Cell Therapy; CD19 CAR T; CD19; CD19 NEX-T; CD19 NEXT; CD19 NEX T; Zola-cel; Zolacabtagene autoleucel

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

Study Arms (1)

Administration of CC-97540

EXPERIMENTAL

Drug: CC-97540; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

CC-97540 DRUG

Specified dose on specified days

Also known as: BMS-986353, Zola-cel, Zolacabtagene autoleucel

Administration of CC-97540

Fludarabine DRUG

Specified dose on specified days

Administration of CC-97540

Cyclophosphamide DRUG

Specified dose on specified days

Administration of CC-97540

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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 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.

Sponsors & Collaborators

• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company: lead

Study Sites (93)

Local Institution - 0106

Scottsdale, Arizona, 85259, United States

NOT YET RECRUITING

Local Institution - 0038

Los Angeles, California, 90027, United States

NOT YET RECRUITING

Local Institution - 0051

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Local Institution - 0093

Newport Beach, California, 92658, United States

NOT YET RECRUITING

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Local Institution - 0105

Denver, Colorado, 80218, United States

NOT YET RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Local Institution - 0073

Orlando, Florida, 32803, United States

NOT YET RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

USF Health

Tampa, Florida, 33612, United States

RECRUITING

Florida Medical Clinic Orlando Health

Zephyrhills, Florida, 33542, United States

RECRUITING

Local Institution - 0076

Athens, Georgia, 30606, United States

NOT YET RECRUITING

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

RECRUITING

Local Institution - 0079

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Local Institution - 0108

Indianapolis, Indiana, 46250, United States

NOT YET RECRUITING

Local Institution - 0086

Baton Rouge, Louisiana, 70836, United States

NOT YET RECRUITING

Local Institution - 0094

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Local Institution - 0096

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

Local Institution - 0011

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Atlantic Health System Overlook Medical Center

Summit, New Jersey, 07901, United States

RECRUITING

Local Institution - 0101

Manhasset, New York, 11030, United States

NOT YET RECRUITING

Local Institution - 0082

New York, New York, 10016, United States

NOT YET RECRUITING

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Local Institution - 0095

New York, New York, 10032, United States

NOT YET RECRUITING

Weill Cornell Medical College

New York, New York, 10065, United States

RECRUITING

Local Institution - 0065

Charlotte, North Carolina, 28211, United States

NOT YET RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Local Institution - 0083

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Local Institution - 0092

Memphis, Tennessee, 38120, United States

NOT YET RECRUITING

Baylor Scott and White Research Institute

Dallas, Texas, 75246, United States

RECRUITING

Local Institution - 0098

Dallas, Texas, 75390-9068, United States

NOT YET RECRUITING

Local Institution - 0104

San Antonio, Texas, 78229, United States

NOT YET RECRUITING

Swedish Medical Center

Seattle, Washington, 98122, United States

RECRUITING

Local Institution - 0016

ABB, Buenos Aires F.D., C1199ABB, Argentina

NOT YET RECRUITING

Local Institution - 0023

Buenos Aires, Buenos Aires F.D., C1118AAT, Argentina

NOT YET RECRUITING

Local Institution - 0107

Buenos Aires, B1629ODT, Argentina

NOT YET RECRUITING

Local Institution - 0077

Córdoba, X5016, Argentina

NOT YET RECRUITING

Medizinische Universität Wien

Vienna, State of Vienna, 1090, Austria

RECRUITING

Uniklinikum Salzburg

Salzburg, 5020, Austria

RECRUITING

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Local Institution - 0021

São Paulo, São Paulo, 01409-001, Brazil

NOT YET RECRUITING

Local Institution - 0058

São Paulo, São Paulo, 01509-010, Brazil

NOT YET RECRUITING

Local Institution - 0022

São Paulo, 05652-900, Brazil

NOT YET RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Local Institution - 0045

Toronto, Ontario, M5G 1X8, Canada

NOT YET RECRUITING

Local Institution - 0099

Toronto, Ontario, M5T 2S8, Canada

NOT YET RECRUITING

Odense Universitetshospital

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Local Institution - 0047

Copenhagen, 2100, Denmark

NOT YET RECRUITING

Local Institution - 0081

Toulouse, Haute-Garonne, 31059, France

NOT YET RECRUITING

CHU Montpellier Lapeyronie Hospital

Montpellier, Hérault, 34295, France

RECRUITING

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

Rennes, 35033, France

RECRUITING

Local Institution - 0109

Strasbourg, 67098, France

NOT YET RECRUITING

Pitie Salpetriere University Hospital

Paris, Île-de-France Region, 75013, France

RECRUITING

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Universitaetsklinikum Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

RECRUITING

Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

Berlin, 10117, Germany

RECRUITING

Universitaetsklinikum Koeln

Cologne, 50937, Germany

RECRUITING

Universitaetsklinikum Erlangen

Erlangen, 91054, Germany

RECRUITING

Local Institution - 0084

Herne, 44649, Germany

NOT YET RECRUITING

Sheba Medical Center

Ramat Gan, Central District, 5262100, Israel

RECRUITING

Local Institution - 0042

Jerusalem, 9112001, Israel

NOT YET RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Rome, Lazio, 00168, Italy

RECRUITING

Local Institution - 0032

Milan, Milano, 20162, Italy

NOT YET RECRUITING

Local Institution - 0044

Rome, Roma, 00165, Italy

NOT YET RECRUITING

Local Institution - 0070

Pisa, Tuscany, 56126, Italy

NOT YET RECRUITING

Local Institution - 0055

Sapporo, Hokkaido, 0608648, Japan

NOT YET RECRUITING

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

RECRUITING

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

Keio university hospital

Shinjuku-ku, Tokyo, 1608582, Japan

RECRUITING

Chiba University Hospital

Chiba, 260-8677, Japan

RECRUITING

Kyushu University Hospital

Fukuoka, 812-8582, Japan

RECRUITING

Okayama University Hospital

Okayama, 700-8558, Japan

RECRUITING

Local Institution - 0053

Osaka, 545-8586, Japan

NOT YET RECRUITING

Szpital Specjalistyczny nr 1 w Bytomiu

Bytom, Silesian Voivodeship, 41-902, Poland

RECRUITING

Narodowy Instytut Onkologii - Oddzial w Gliwicach

Gliwice, Silesian Voivodeship, 44-101, Poland

RECRUITING

Local Institution - 0013

Lisbon, Lisbon District, 1649-035, Portugal

NOT YET RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

RECRUITING

Local Institution - 0088

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

NOT YET RECRUITING

Local Institution - 0087

Madrid, 28006, Spain

NOT YET RECRUITING

H.R.U Málaga - Hospital General

Málaga, 29011, Spain

RECRUITING

Local Institution - 0089

Murcia, 30120, Spain

NOT YET RECRUITING

Local Institution - 0061

London, London, City of, NW1 2PG, United Kingdom

WITHDRAWN

University College London Hospital

London, London, City of, NW1 2PG, United Kingdom

RECRUITING

King's College Hospital

London, London, City of, SE5 9RL, United Kingdom

RECRUITING

Local Institution - 0090

Metropolitan Borough of Wirral, Merseyside, L63 4JY, United Kingdom

NOT YET RECRUITING

Local Institution - 0102

Crownhill, Plymouth, PL6 8DH, United Kingdom

NOT YET RECRUITING

Local Institution - 0091

Liverpool, L9 7AL, United Kingdom

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

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: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

JP (8); AR (4); PL (2); ES (6); DE (6); PT (1); IL (2); FR (5); CA (3); IT (4); AU (2); US (38); BE (1); DK (2); GB (6); BR (3)