Study of CC-97540 (BMS-986353), CD19-CAR T Cells, in Participants with Active SLE Despite Immunosuppressants (Breakfree-SLE)

Prior treatment

• Other diseases or conditions, or be receiving treatments, that might make it hard to tell if the study drug, CC-97540, is working
• Having had certain types of cell therapies or a stem cell transplant
• Having received a live vaccine within six weeks before starting the study drug

Other illness

• Uncontrolled infections
• Serious heart conditions

Lab values

• Cancer or a disease where the body makes too many lymphocytes, unless they have been free of the disease for at least two years

Other

• Unresolved problems with their central nervous system
• Women who are pregnant, nursing, or planning to become pregnant
• Poor organ function, as determined by lab tests at the study site

• Be at least 16 years old and must have a body weight of ≥ 40 kg
• Have Systemic Lupus Erythematosus (SLE), as defined by the EULAR/ACR 2019 criteria
• Have tried glucocorticoids and at least two different immune-suppressing drugs for SLE, for at least three months each, but these treatments didn't work well enough
• Have active SLE determined by a scoring system called BILAG (a tool to measure SLE disease activity), and by testing for certain proteins in the blood that are signs of SLE
• Have a specific type of kidney disease related to SLE (lupus nephritis [LN]), they must have had a kidney biopsy within the last six months.