KYSA-1: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Lupus Nephritis, Lupus Nephritis - World Health Organization (WHO) Class III, Lupus Nephritis - WHO Class IV
In brief
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis
Key facts
- Study ID
- NCT05938725
- Run by
- Kyverna Therapeutics
- People needed
- 6
- Starts
- 2023-04-28
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2025-10-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years
- Clinical diagnosis of SLE according to 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria
- Biopsy-proven proliferative LN Class III or IV according to 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
- 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
- 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
You may not qualify if…
- Rapidly progressive glomerulonephritis; history of or currently active severe central nervous system (CNS) lupus, including cerebritis, cerebrovascular accident, and seizures
- Prior treatment with cellular immunotherapy (CAR-T) or gene therapy product directed at any target
- History of allogeneic or autologous stem cell transplant
- Evidence of active hepatitis B or hepatitis C infection
- Positive serology for HIV
- Primary immunodeficiency
- History of splenectomy
- 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
- Impaired cardiac function or clinically significant cardiac disease
- Previous or concurrent malignancy with the following exceptions:
- Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening)
- In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening
- A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening
Where it is running
- Stanford University Medical Center — Palo Alto, California, United States
- University of Colorado — Denver, Colorado, United States
- University of Massachusetts Worcester — Worcester, Massachusetts, United States
- Northwell Health — Great Neck, New York, United States
- Ohio State University Wexner Medical Center — Columbus, Ohio, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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