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)

Korábbi kezelés

• 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.

Más betegség

• Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE.

Életkor

• 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.

Egyéb

• IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant.
• Participant must not have inadequate organ function.
• Other protocol-defined inclusion/exclusion criteria apply.

• 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.