KYSA-1: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis

Exclusion Criteria

• •1. Rapidly progressive glomerulonephritis; history of or currently active severe central nervous system (CNS) lupus, including cerebritis, cerebrovascular accident, and seizures
• •2. Prior treatment with cellular immunotherapy (CAR-T) or gene therapy product directed at any target
• •3. History of allogeneic or autologous stem cell transplant
• •4. Evidence of active hepatitis B or hepatitis C infection
• •5. Positive serology for HIV
• •6. Primary immunodeficiency
• •7. History of splenectomy
• •8. History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder investigator considers would increase the risk for the subject
• •9. Impaired cardiac function or clinically significant cardiac disease
• •10. Previous or concurrent malignancy with the following exceptions:
• •1. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening)
• •2. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening
• •3. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening