Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility 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
- 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
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No