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CD19-targeted CAR T cell therapy (Zola-cel) for active SLE and lupus nephritis

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)

Phase 2 Interventional Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · NCT07015983

This will try a one-time CD19-targeted CAR T cell treatment called Zola-cel in people with active SLE or lupus nephritis who have not improved on steroids and at least two immunosuppressants.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment89 (estimated)
Ages16 Years and up
SexAll
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company Industry-sponsored
Drugs / interventionsCAR T, chemotherapy
Locations93 sites (Scottsdale, Arizona and 92 other locations)
Trial IDNCT07015983 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial tests CC-97540 (also called BMS-986353 or Zola-cel), a CD19-directed NEX-T CAR T cell therapy, after a short course of lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Eligible participants must meet EULAR/ACR 2019 criteria for SLE and have active disease despite glucocorticoids and two or more immunosuppressants. The study will measure safety, drug levels, and clinical response after infusion, with close inpatient and outpatient monitoring for cytokine release syndrome and other CAR T–related toxicities. Sites are in the United States and require specialized center-based delivery and follow-up care.

Who should consider this trial

Good fit: Ideal candidates are adults with active SLE or lupus nephritis who meet EULAR/ACR criteria and have an inadequate response to glucocorticoids plus at least two immunosuppressant therapies.

Not a fit: Patients are unlikely to benefit if they have prior CAR T or genetically modified T cell therapy, prior stem cell or organ transplant, uncontrolled cardiovascular or CNS disease, active malignancy, pregnancy, or otherwise well-controlled SLE on current therapy.

Why it matters

Potential benefit: If successful, the therapy could bring prolonged remission by markedly reducing disease-causing B cells and reduce long-term need for chronic immunosuppression.

How similar studies have performed: Small case series and early clinical experiences of CD19-directed CAR T cells in refractory autoimmune diseases, including limited reports in SLE, have shown promising remissions but are based on few patients with short follow-up.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Scottsdale, Arizona and 92 other locations

+43 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lupus Erythematosus, SystemicLupus NephritisLupusSLELNCAR TCell TherapyCD19 CAR T
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.