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Lupus Erythematosus, SystemicPhase 2NCT07015983

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)

A Phase 2 study testing CC-97540, Fludarabine and Cyclophosphamide in people with Lupus Erythematosus, Systemic and Lupus Nephritis, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 97 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
CC-97540, Fludarabine and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
97 sitesin 16 countries
Study dates
14 Jul 2025to 15 Jun 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

97 sites in 16 countries.

97 sites in 16 countries

United States41 sites

  • Local Institution - 0096

    Ann Arbor, Michigan, 48109

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Local Institution - 0079

    Atlanta, Georgia, 30322

  • Northside Hospital

    Atlanta, Georgia, 30342

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Local Institution - 0086

    Baton Rouge, Louisiana, 70836

  • Local Institution - 0094

    Boston, Massachusetts, 02114

  • Carolinas HealthCare System SouthPark

    Charlotte, North Carolina, 28211

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Baylor Scott and White Research Institute

    Dallas, Texas, 75246

  • Local Institution - 0098

    Dallas, Texas, 75390-9068

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Local Institution - 0108

    Indianapolis, Indiana, 46250

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Local Institution - 0038

    Los Angeles, California, 90027

  • Local Institution - 0051

    Los Angeles, California, 90095

  • Local Institution - 0101

    Manhasset, New York, 11030

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

  • University of Miami Hospital and Clinics, Sylvester Cancer Center

    Miami, Florida, 33136

  • Local Institution - 0082

    New York, New York, 10016

  • Hospital for Special Surgery

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • Columbia University Pediatrics

    New York, New York, 10032

  • Weill Cornell Medical College

    New York, New York, 10065

  • Local Institution - 0093

    Newport Beach, California, 92663

  • Local Institution - 0073

    Orlando, Florida, 32803

  • Lucile Packard Children's Hospital

    Palo Alto, California, 94304

  • Local Institution - 0083

    Philadelphia, Pennsylvania, 19104

  • Local Institution - 0106

    Phoenix, Arizona, 85054

  • Local Institution - 0011

    Rochester, Minnesota, 55905

  • Local Institution - 0104

    San Antonio, Texas, 78229

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Local Institution - 0110

    Shreveport, Louisiana, 71101

  • Local Institution - 0111

    Stony Brook, New York, 11794

  • Atlantic Health System Overlook Medical Center

    Summit, New Jersey, 07901

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • USF Health

    Tampa, Florida, 33612

  • Local Institution - 0135

    Winston-Salem, North Carolina, 27106

  • Florida Medical Clinic Orlando Health

    Zephyrhills, Florida, 33542

Other trials in United States

Japan8 sites

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431

  • Chiba University Hospital

    Chiba, 260-8677

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Okayama University Hospital

    Okayama, 700-8558

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 0608648

  • Keio university hospital

    Shinjuku-ku, Tokyo, 1608582

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

France6 sites

  • CHU Montpellier Lapeyronie Hospital

    Montpellier, Hérault, 34295

  • Pitie Salpetriere University Hospital

    Paris, Île-de-France Region, 75013

  • Local Institution - 0134

    Paris, Île-de-France Region, 75015

  • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

    Rennes, 35033

  • Local Institution - 0109

    Strasbourg, 67098

  • Local Institution - 0081

    Toulouse, Haute-Garonne, 31059

Other trials in France

Germany6 sites

  • Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

    Berlin, 10117

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

  • Rheumazentrum Ruhrgebiet

    Herne, 44649

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Universitaetsklinikum Magdeburg

    Magdeburg, Saxony-Anhalt, 39120

Other trials in Germany

Spain6 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035

  • Local Institution - 0088

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona [Barcelona], 08950

  • Hospital La Princesa

    Madrid, 28006

  • H.R.U Málaga - Hospital General

    Málaga, 29011

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120

Other trials in Spain

United Kingdom5 sites

  • Derriford Hospital, University Hospitals Plymouth NHS Trust

    Crownhill, Plymouth, PL6 8DH

  • Local Institution - 0091

    Liverpool, L9 7AL

  • University College London Hospital

    London, London, City of, NW1 2PG

  • King's College Hospital

    London, London, City of, SE5 9RL

  • Local Institution - 0090

    Metropolitan Borough of Wirral, Merseyside, L63 4JY

Other trials in United Kingdom

Argentina4 sites

  • Hospital Italiano de Buenos Aires

    ABB, Buenos Aires F.D., C1199ABB

  • Hospital Aleman

    Buenos Aires, Buenos Aires F.D., C1118AAT

  • Local Institution - 0107

    Buenos Aires, B1629ODT

  • Local Institution - 0077

    Córdoba, X5016

Other trials in Argentina

Italy4 sites

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Milano, 20162

  • Local Institution - 0070

    Pisa, Tuscany, 56126

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

    Rome, Lazio, 00168

  • Ospedale Pediatrico Bambino Gesù IRCCS

    Rome, Roma, 00165

Other trials in Italy

Brazil3 sites

  • Local Institution - 0021

    São Paulo, São Paulo, 01409-001

  • Local Institution - 0058

    São Paulo, São Paulo, 01509-010

  • Local Institution - 0022

    São Paulo, 05652-900

Other trials in Brazil

Canada3 sites

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • Local Institution - 0099

    Toronto, Ontario, M5T 2S8

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Denmark3 sites

  • Local Institution - 0047

    Copenhagen, Capital Region, 2100

  • Local Institution - 0132

    Odense, Region Syddanmark, 5000

  • Odense Universitetshospital

    Odense, Region Syddanmark, 5000

Other trials in Denmark

Austria2 sites

  • Uniklinikum Salzburg

    Salzburg, 5020

  • Medizinische Universität Wien

    Vienna, State of Vienna, 1090

Other trials in Austria

Israel2 sites

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Sheba Medical Center

    Ramat Gan, Central District, 5262100

Other trials in Israel

Poland2 sites

  • Szpital Specjalistyczny nr 1 w Bytomiu

    Bytom, Silesian Voivodeship, 41-902

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach

    Gliwice, Silesian Voivodeship, 44-101

Other trials in Poland

Belgium1 site

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Portugal1 site

  • Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria

    Lisbon, Lisbon District, 1649-035

Other trials in Portugal

About this study

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)

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.

Being tested
CC-97540, Fludarabine, Cyclophosphamide
Keywords
Lupus, SLE, LN, CAR T, Cell Therapy, CD19 CAR T, CD19, CD19 NEX-T, CD19 NEXT, CD19 NEX T, Zola-cel, Zolacabtagene autoleucel
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-97540Drug

    Also called BMS-986353, Zola-cel, Zolacabtagene autoleucel

    Specified dose on specified days

  • FludarabineDrug

    Specified dose on specified days

  • CyclophosphamideDrug

    Specified dose on specified days

Study groups in NCT07015983
Study groupRoleWhat they receive
Administration of CC-97540ExperimentalNot described
Receives: Drug: CC-97540; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission

    Measured: At month 6

Secondary outcomes (36)

  1. Complete renal response (CRR) for participants with baseline lupus nephritis (LN)

    Measured: Up to Month 60

  2. Participants with drug-free DORIS remission

    Measured: Up to month 60

  3. CRR for participants with baseline LN

    Measured: Up to month 60

  4. Modified CRR for participants with baseline LN

    Measured: Up to month 60

  5. Number of participants achieving Lupus Low Disease Activity State (LLDAS) with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥6

    Measured: Up to month 60

  6. Number of participants achieving SLE Responder Index (SRI) - 4 with baseline SLEDAI ≥6

    Measured: Up to month 60

  7. Number of participants with flares as assessed by SLEDAI flare index

    Measured: Up to month 60

  8. Severity of participants with flares as assessed by SLEDAI flare index

    Measured: Up to month 60

  9. Change from baseline in proteinuria

    Measured: Up to month 60

  10. Change from baseline in estimated glomerular filtration rate (eGFR)

    Measured: Up to month 60

  11. Change from baseline in Systemic Lupus International Collaborating Clinics (SLICC)/ACR (American College of Rheumatology) damage index

    Measured: Up to month 60

  12. Percentage of participants achieving maintenance of drug-free DORIS remission

    Measured: Up to month 60

  13. Percentage of participants achieving maintenance of LLDAS

    Measured: Up to month 60

  14. Percentage of participants achieving maintenance of SRI-4

    Measured: Up to month 60

  15. Time from first response to loss of response for drug-free DORIS remission

    Measured: Up to month 60

  16. Time from first response to loss of response for LLDAS

    Measured: Up to month 60

  17. Time from first response to loss of response for SRI-4

    Measured: Up to month 60

  18. Time from baseline to first drug-free DORIS remission

    Measured: Up to month 60

  19. Time from baseline to LLDAS

    Measured: Up to month 60

  20. Time from baseline to SRI-4

    Measured: Up to month 60

  21. Duration of drug-free status

    Measured: Up to month 60

  22. Percentage of participants achieving DORIS remission regardless of drug-free status

    Measured: Up to month 60

  23. Glucocorticoid used post-infusion for SLE treatment

    Measured: Up to month 60

  24. Change of serum autoantibodies from baseline

    Measured: Up to month 60

  25. Change in complement factor (C3 and C4) levels from baseline

    Measured: Up to month 60

  26. Change from baseline in patient reported outcomes (PRO) as assessed by FACIT-Fatigue

    Measured: Up to month 60

  27. Change from baseline in PRO as assessed by SF 36 v2 Acute

    Measured: Up to month 60

  28. Change from baseline in PRO as assessed by EQ-5D-5L

    Measured: Up to month 60

  29. Change from baseline in PRO as assessed by Patient Global Impression of Severity (PGI-S) Pain

    Measured: Up to month 60

  30. Change from baseline in PRO as assessed by PGI-S Fatigue

    Measured: Up to month 60

  31. Patient Global Impression of Change (PGI-C) Pain

    Measured: Up to month 60

  32. PGI-C Fatigue

    Measured: Up to month 60

  33. Number of participants with Adverse Events (AEs)

    Measured: Up to month 60

  34. Number of participants with serious AEs (SAEs)

    Measured: Up to month 60

  35. Number of participants with AESIs (AEs of Special Interest)

    Measured: Up to month 60

  36. Number of participants with clinically significant laboratory abnormalities

    Measured: Up to month 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start14 Jul 2025
  3. Primary completion17 May 2028 (estimated)
  4. Study completion15 Jun 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
89 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07015983
Sponsor's protocol ID
CA061-1011
Other IDs
2024-519278-37
Status last verified
Jul 2026
First submitted
30 May 2025
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CC-97540, Fludarabine and Cyclophosphamide in people with Lupus Erythematosus, Systemic and Lupus Nephritis, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 97 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Japan, France, Germany, Spain and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission (time frame: At month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07015983.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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