Status:
RECRUITING
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)
Lead Sponsor:
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Conditions:
Lupus Erythematosus, Systemic
Lupus Nephritis
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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 respo...
Eligibility Criteria
Inclusion
- 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
- 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 during participation in the study.
- 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.
Key Trial Info
Start Date :
July 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2032
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT07015983
Start Date
July 14 2025
End Date
June 15 2032
Last Update
February 27 2026
Active Locations (97)
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1
Local Institution - 0009
Birmingham, Alabama, United States, 35294-3300
2
Local Institution - 0080
Scottsdale, Arizona, United States, 85258
3
Local Institution - 0038
Los Angeles, California, United States, 90027
4
Local Institution - 0051
Los Angeles, California, United States, 90095