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)
Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
trial.available_in:
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Overview
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 participate
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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