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 Against
   Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria

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

   4. Positive anti-nuclear antibody (ANA) (titer ≥1:80 ), anti-dsDNA (≥30 IU/mL on
   enzyme-linked immunosorbent assay [ELISA]), or anti-Smith at screening or by
   documented 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), per Centers
   for Disease Control and Prevention (CDC) or institutional guidelines for immune
   compromised individuals

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