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

Inclusion Criteria:

1. Age ≥18 years

2. Clinical diagnosis of SLE according to 2019 European League AgainstRheumatism/American College of Rheumatology (EULAR/ACR) classification criteria

3. Biopsy-proven proliferative LN Class III or IV according to 2018 InternationalSociety of Nephrology/Renal Pathology Society (ISN/RPS) criteria

4. Positive anti-nuclear antibody (ANA) (titer ≥1:80 ), anti-dsDNA (≥30 IU/mL onenzyme-linked immunosorbent assay [ELISA]), or anti-Smith at screening or bydocumented medical history

5. Up to date on recommended vaccinations, including against coronavirus disease 2019 (COVID-19)/ severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), perCenters for Disease Control and Prevention (CDC) or institutional guidelines forimmune compromised individuals

Exclusion Criteria:

1. Rapidly progressive glomerulonephritis; history of or currently active severecentral nervous system (CNS) lupus, including cerebritis, cerebrovascular accident,and seizures

2. Prior treatment with cellular immunotherapy (CAR-T) or gene therapy product directedat 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 movementdisorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologicdisorder 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:

11. Adequately treated basal cell or squamous cell carcinoma (adequate woundhealing is required prior to screening)

12. In situ carcinoma of the cervix or breast, treated curatively and withoutevidence of recurrence for at least 3 years prior to screening

13. A primary malignancy which has been completely resected, or treated, and is incomplete remission for at least 5 years prior to screening