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.
Eligibility
Key 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.
Key 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, or stem cell transplant. Washout periods may be required.
- Participants must not have received live vaccines within 6 weeks before CC-97540 administration.
- Participant must not have inadequate organ function.
- Other protocol defined inclusion/exclusion criteria apply.