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, 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)
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
89 participants
Jul 14, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria6
- 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.
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Interventions
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Locations(93)
View Full Details on ClinicalTrials.gov
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NCT07015983