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NCT07015983PHASE2Recruiting

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)

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Start Date

7/14/2025

Completion Date

6/15/2032

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 Criteria

Age Range: 16 years to No maximum

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.

Interventions

DRUG

CC-97540

DRUG

Fludarabine

DRUG

Cyclophosphamide

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Conditions

Lupus Erythematosus, SystemicLupus Nephritis

Locations

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

Local Institution - 0105

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

Local Institution - 0095

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

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

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

Local Institution - 0084

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

Local Institution - 0044

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

Local Institution - 0061

London, London, City of NW1 2PG

United Kingdom

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