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) - CA061-1011
Updated: 4 February, 2026 | ClinicalTrials.gov
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Recruiting
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 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.
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