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)
Recruiting now Phase 2 NCT07015983
Run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · for 16 and older · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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.
🚫 You may not be able to join if…
- 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
- Local Institution - 0106, Phoenix, Arizona, United States
- Local Institution - 0038, Los Angeles, California, United States
- Local Institution - 0051, Los Angeles, California, United States
- Local Institution - 0093, Newport Beach, California, United States
- Lucile Packard Children's Hospital, Palo Alto, California, United States
- University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
- Local Institution - 0105, Denver, Colorado, United States
- Mayo Clinic in Florida, Jacksonville, Florida, United States
- University of Miami Hospital and Clinics, Sylvester Cancer Center, Miami, Florida, United States
- Local Institution - 0073, Orlando, Florida, United States
- Moffitt Cancer Center, Tampa, Florida, United States
- USF Health, Tampa, Florida, United States
+ 84 more sites.
Who to contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07015983.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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