A Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: July 14, 2025
End Date: June 15, 2032
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
8559073286
8559073286
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- 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.
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Conditions:
- Lupus Erythematosus, Systemic
- Lupus Nephritis