A Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

Last updated: September 8, 2025
Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Overall Status: Active - Recruiting

Phase

2

Condition

Lupus

Kidney Disease

Nephritis

Treatment

Fludarabine

Cyclophosphamide

CC-97540

Clinical Study ID

NCT07015983
CA061-1011
2024-519278-37
  • Ages > 16
  • All Genders

Study 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

Inclusion

Key Inclusion Criteria

  • Participants must meet EULAR/ACR 2019 criteria for SLE.

  • Participants must have an inadequate response to appropriate doses ofglucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months.

  • Participants must have active disease when signing ICF.

Exclusion

Key Exclusion Criteria:

  • Participants must not have other diseases, conditions, or treatments that mayconfound interpretation of the effects of CC-97540 in SLE.

  • Uncontrolled or clinically significant cardiovascular conditions or CNS pathologyparticipants must not have prior history of malignancies or lymphoproliferativedisease, unless the participant has been free of the disease for ≥ 2 years, exceptfor some non-invasive malignancies.

  • IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnantduring participation in the study.

  • Participants must not have prior treatment with CAR T cell therapy, geneticallymodified T cell therapy, or stem cell transplant. Washout periods may be required.

  • Participants must not have received live vaccines within 6 weeks before CC-97540administration.

  • Participant must not have inadequate organ function.

  • Other protocol defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 89
Treatment Group(s): 3
Primary Treatment: Fludarabine
Phase: 2
Study Start date:
July 14, 2025
Estimated Completion Date:
June 15, 2032

Connect with a study center

  • Local Institution - 0016

    ABB, Buenos Aires F.D. 3433955 C1199ABB
    Argentina

    Site Not Available

  • Local Institution - 0017

    ABB, Buenos Aires F.D. 3433955 C1199ABB
    Argentina

    Site Not Available

  • Local Institution - 0023

    Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1118AAT
    Argentina

    Site Not Available

  • Local Institution - 0023

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1118AAT
    Argentina

    Site Not Available

  • Local Institution - 0077

    Córdoba 3860259, X5016
    Argentina

    Site Not Available

  • Local Institution - 0037

    Vienna 2761369, Vienna 2761367 1090
    Austria

    Site Not Available

  • Local Institution - 0037

    Vienna, Wien 1090
    Austria

    Site Not Available

  • Local Institution - 0031

    Salzburg, 5020
    Austria

    Site Not Available

  • Local Institution - 0031

    Salzburg 2766824, 5020
    Austria

    Site Not Available

  • Local Institution - 0020

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • Local Institution - 0020

    Leuven 2792482, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • Local Institution - 0058

    Sao Paulo, São Paulo 01509-010
    Brazil

    Site Not Available

  • Local Institution - 0058

    São Paulo 3448439, São Paulo 3448433 01509-010
    Brazil

    Site Not Available

  • Local Institution - 0021

    São Paulo, 01409-902
    Brazil

    Site Not Available

  • Local Institution - 0022

    São Paulo, 05652-900
    Brazil

    Site Not Available

  • Local Institution - 0021

    São Paulo 3448439, 01409-902
    Brazil

    Site Not Available

  • Local Institution - 0022

    São Paulo 3448439, 05652-900
    Brazil

    Site Not Available

  • Local Institution - 0048

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Local Institution - 0048

    Vancouver 6173331, British Columbia 5909050 V5Z 1M9
    Canada

    Site Not Available

  • Local Institution - 0045

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Local Institution - 0045

    Toronto 6167865, Ontario 6093943 M5G 1X8
    Canada

    Site Not Available

  • Local Institution - 0056

    Odense 2615876, Region Syddanmark 6418542 5000
    Denmark

    Site Not Available

  • Local Institution - 0056

    Odense, Syddanmark 5000
    Denmark

    Site Not Available

  • Local Institution - 0047

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Local Institution - 0047

    Copenhagen 2618425, 2100
    Denmark

    Site Not Available

  • Local Institution - 0018

    Montpellier, Hérault 34295
    France

    Site Not Available

  • Local Institution - 0018

    Montpellier 2992166, Hérault 34295
    France

    Site Not Available

  • Local Institution - 0064

    Paris, Île-de-France 75013
    France

    Site Not Available

  • Local Institution - 0064

    Paris 2988507, Île-de-France Region 3012874 75013
    France

    Site Not Available

  • Local Institution - 0019

    Rennes, 35033
    France

    Site Not Available

  • Local Institution - 0019

    Rennes 2983990, 35033
    France

    Site Not Available

  • Local Institution - 0029

    Köln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • Local Institution - 0029

    Cologne 2886242, North Rhine-Westphalia 2861876 50937
    Germany

    Site Not Available

  • Local Institution - 0028

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Local Institution - 0030

    Magdeburg, Sachsen-Anhalt 39120
    Germany

    Site Not Available

  • Local Institution - 0028

    Leipzig 2879139, Saxony 2842566 04103
    Germany

    Site Not Available

  • Local Institution - 0030

    Magdeburg 2874545, Saxony-Anhalt 2842565 39120
    Germany

    Site Not Available

  • Local Institution - 0026

    Berlin, 10117
    Germany

    Site Not Available

  • Local Institution - 0026

    Berlin 2950159, 10117
    Germany

    Site Not Available

  • Local Institution - 0027

    Erlangen, 91054
    Germany

    Site Not Available

  • Local Institution - 0027

    Erlangen 2929567, 91054
    Germany

    Site Not Available

  • Local Institution - 0043

    Ramat Gan, Central District 294904 5262100
    Israel

    Site Not Available

  • Local Institution - 0042

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Local Institution - 0042

    Jerusalem 281184, 9112001
    Israel

    Site Not Available

  • Local Institution - 0025

    Roma, Lazio 00168
    Italy

    Site Not Available

  • Local Institution - 0025

    Rome 3169070, Lazio 3174976 00168
    Italy

    Site Not Available

  • Local Institution - 0032

    Milan, Milano 20162
    Italy

    Site Not Available

  • Local Institution - 0032

    Milan 3173435, Milano 20162
    Italy

    Site Not Available

  • Local Institution - 0044

    Rome, Roma 00165
    Italy

    Site Not Available

  • Local Institution - 0044

    Rome 3169070, Roma 00165
    Italy

    Site Not Available

  • Local Institution - 0070

    Pisa, Toscana 56126
    Italy

    Site Not Available

  • Local Institution - 0070

    Pisa 3170647, Tuscany 3165361 56126
    Italy

    Site Not Available

  • Local Institution - 0055

    Sapporo, Hokkaido 0608648
    Japan

    Site Not Available

  • Local Institution - 0055

    Sapporo 2128295, Hokkaido 2130037 0608648
    Japan

    Site Not Available

  • Local Institution - 0072

    Yokohama, Kanagawa 236-0004
    Japan

    Site Not Available

  • Local Institution - 0072

    Yokohama 1848354, Kanagawa 1860291 236-0004
    Japan

    Site Not Available

  • Local Institution - 0068

    Bunkyo-ku, Tokyo 1850144 113-8431
    Japan

    Site Not Available

  • Local Institution - 0069

    Shinjuku-ku, Tokyo 1850144 1608582
    Japan

    Site Not Available

  • Local Institution - 0067

    Chiba, 260-8677
    Japan

    Site Not Available

  • Local Institution - 0067

    Chiba 2113015, 260-8677
    Japan

    Site Not Available

  • Local Institution - 0054

    Fukuoka, 812-8582
    Japan

    Site Not Available

  • Local Institution - 0054

    Fukuoka 1863967, 812-8582
    Japan

    Site Not Available

  • Local Institution - 0063

    Okayama, 700-8558
    Japan

    Site Not Available

  • Local Institution - 0063

    Okayama 1854383, 700-8558
    Japan

    Site Not Available

  • Local Institution - 0053

    Osaka, 545-8586
    Japan

    Site Not Available

  • Local Institution - 0053

    Osaka 1853909, 545-8586
    Japan

    Site Not Available

  • Local Institution - 0046

    Amsterdam, Noord-Holland 1105 AZ
    Netherlands

    Site Not Available

  • Local Institution - 0046

    Amsterdam 2759794, North Holland 2749879 1105 AZ
    Netherlands

    Site Not Available

  • Local Institution - 0024

    Bytom 3101950, Silesian Voivodeship 3337497 41-902
    Poland

    Site Not Available

  • Local Institution - 0049

    Gliwice 3099230, Silesian Voivodeship 3337497 44-101
    Poland

    Site Not Available

  • Local Institution - 0034

    Łódź, Łódzkie 93-513
    Poland

    Site Not Available

  • Local Institution - 0034

    Lodz 3093133, Łódź Voivodeship 3337493 93-513
    Poland

    Site Not Available

  • Local Institution - 0024

    Bytom, Śląskie 41-902
    Poland

    Site Not Available

  • Local Institution - 0049

    Gliwice, Śląskie 44-101
    Poland

    Site Not Available

  • Local Institution - 0013

    Lisbon, Lisboa 1649-035
    Portugal

    Site Not Available

  • Local Institution - 0013

    Lisbon 2267057, Lisbon District 2267056 1649-035
    Portugal

    Site Not Available

  • Local Institution - 0015

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Local Institution - 0015

    Barcelona 3128760, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Local Institution - 0071

    Esplugues de Llobregat, Barcelona [Barcelona] 08950
    Spain

    Site Not Available

  • Local Institution - 0071

    Esplugues de Llobregat 3122826, Barcelona [Barcelona] 08950
    Spain

    Site Not Available

  • Local Institution - 0014

    Málaga, 29011
    Spain

    Site Not Available

  • Local Institution - 0014

    Málaga 2514256, 29011
    Spain

    Site Not Available

  • Local Institution - 0050

    London, London, City Of SE5 9RL
    United Kingdom

    Site Not Available

  • Local Institution - 0057

    London, London, City Of W1T 7HA
    United Kingdom

    Site Not Available

  • Local Institution - 0060

    London, London, City Of NW1 2PG
    United Kingdom

    Site Not Available

  • Local Institution - 0061

    London, London, City Of NW1 2PG
    United Kingdom

    Site Not Available

  • Local Institution - 0050

    London 2643743, London, City of SE5 9RL
    United Kingdom

    Site Not Available

  • Local Institution - 0057

    London 2643743, London, City of W1T 7HA
    United Kingdom

    Site Not Available

  • Local Institution - 0060

    London 2643743, London, City of NW1 2PG
    United Kingdom

    Site Not Available

  • Local Institution - 0061

    London 2643743, London, City of NW1 2PG
    United Kingdom

    Site Not Available

  • Local Institution - 0009

    Birmingham, Alabama 35294-3300
    United States

    Site Not Available

  • Local Institution - 0009

    Birmingham 4049979, Alabama 4829764 35294-3300
    United States

    Site Not Available

  • Local Institution - 0038

    Los Angeles, California 90027
    United States

    Site Not Available

  • Local Institution - 0051

    Los Angeles, California 90095
    United States

    Site Not Available

  • Local Institution - 0035

    Palo Alto, California 94304
    United States

    Site Not Available

  • Local Institution - 0038

    Los Angeles 5368361, California 5332921 90027
    United States

    Site Not Available

  • Local Institution - 0051

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Lucile Packard Children's Hospital

    Palo Alto 5380748, California 5332921 94304
    United States

    Active - Recruiting

  • Local Institution - 0033

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • Local Institution - 0006

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Local Institution - 0002

    Miami, Florida 33136
    United States

    Site Not Available

  • Local Institution - 0008

    Tampa, Florida 33612
    United States

    Site Not Available

  • Local Institution - 0036

    Tampa, Florida 33612
    United States

    Site Not Available

  • Local Institution - 0062

    Zephyrhills, Florida 33542
    United States

    Site Not Available

  • Mayo Clinic in Florida

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Active - Recruiting

  • Local Institution - 0002

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Local Institution - 0073

    Orlando 4167147, Florida 4155751 32804
    United States

    Site Not Available

  • Local Institution - 0008

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Local Institution - 0036

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Local Institution - 0062

    Zephyrhills 4178941, Florida 4155751 33542
    United States

    Site Not Available

  • Local Institution - 0074

    Honolulu 5856195, Hawaii 5855797 96813
    United States

    Site Not Available

  • Local Institution - 0052

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Local Institution - 0052

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Local Institution - 0011

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Local Institution - 0011

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Atlantic Health System Overlook Medical Center

    Summit, New Jersey 07901
    United States

    Site Not Available

  • Local Institution - 0001

    Summit, New Jersey 07901
    United States

    Site Not Available

  • Atlantic Health System Overlook Medical Center

    Summit 5105127, New Jersey 5101760 07901
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Local Institution - 0004

    New York, New York 10029
    United States

    Site Not Available

  • Local Institution - 0005

    New York, New York 10032
    United States

    Site Not Available

  • Local Institution - 0039

    New York, New York 10065
    United States

    Site Not Available

  • Local Institution - 0040

    New York, New York 10021
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • Local Institution - 0005

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Local Institution - 0039

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • Local Institution - 0040

    New York 5128581, New York 5128638 10021
    United States

    Site Not Available

  • Local Institution - 0010

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Local Institution - 0065

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Local Institution - 0010

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • Local Institution - 0065

    Charlotte 4460243, North Carolina 4482348 28211
    United States

    Site Not Available

  • Local Institution - 0012

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Local Institution - 0003

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Local Institution - 0012

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Site Not Available

  • Local Institution - 0003

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Local Institution - 0041

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Local Institution - 0041

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Site Not Available

  • Baylor Scott and White Research Institute

    Dallas, Texas 75246
    United States

    Site Not Available

  • Local Institution - 0059

    Dallas, Texas 75246
    United States

    Site Not Available

  • Baylor Scott and White Research Institute

    Dallas 4684888, Texas 4736286 75246
    United States

    Active - Recruiting

  • Local Institution - 0007

    Seattle, Washington 98122
    United States

    Site Not Available

  • Local Institution - 0007

    Seattle 5809844, Washington 5815135 98122
    United States

    Site Not Available

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