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NCT Number: NCT07015983

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)

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.

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Key information

Conditions

Lupus Erythematosus, Systemic Autoimmune Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Nephritis Male Urogenital Diseases Nephritis Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Italiano de Buenos Aires, ABB, Buenos Aires F.D., Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CC-97540

Drug

Specified dose on specified days

Other names: BMS-986353, Zola-cel, Zolacabtagene autoleucel

Fludarabine

Drug

Specified dose on specified days

Cyclophosphamide

Drug

Specified dose on specified days

Primary outcomes

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

    Time frame: At month 6

Secondary outcomes

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

    Time frame: Up to Month 60

  2. Participants with drug-free DORIS remission

    Time frame: Up to month 60

  3. CRR for participants with baseline LN

    Time frame: Up to month 60

  4. Modified CRR for participants with baseline LN

    Time frame: 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

    Time frame: Up to month 60

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

    Time frame: Up to month 60

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

    Time frame: Up to month 60

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

    Time frame: Up to month 60

  9. Change from baseline in proteinuria

    Time frame: Up to month 60

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

    Time frame: Up to month 60

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

    Time frame: Up to month 60

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

    Time frame: Up to month 60

  13. Percentage of participants achieving maintenance of LLDAS

    Time frame: Up to month 60

  14. Percentage of participants achieving maintenance of SRI-4

    Time frame: Up to month 60

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

    Time frame: Up to month 60

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

    Time frame: Up to month 60

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

    Time frame: Up to month 60

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

    Time frame: Up to month 60

  19. Time from baseline to LLDAS

    Time frame: Up to month 60

  20. Time from baseline to SRI-4

    Time frame: Up to month 60

  21. Duration of drug-free status

    Time frame: Up to month 60

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

    Time frame: Up to month 60

  23. Glucocorticoid used post-infusion for SLE treatment

    Time frame: Up to month 60

  24. Change of serum autoantibodies from baseline

    Time frame: Up to month 60

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

    Time frame: Up to month 60

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

    Time frame: Up to month 60

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

    Time frame: Up to month 60

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

    Time frame: Up to month 60

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

    Time frame: Up to month 60

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

    Time frame: Up to month 60

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

    Time frame: Up to month 60

  32. PGI-C Fatigue

    Time frame: Up to month 60

  33. Number of participants with Adverse Events (AEs)

    Time frame: Up to month 60

  34. Number of participants with serious AEs (SAEs)

    Time frame: Up to month 60

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

    Time frame: Up to month 60

  36. Number of participants with clinically significant laboratory abnormalities

    Time frame: Up to month 60

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2028
Study completion
2032
First posted
Jun 11, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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