KYSA-1: Study on Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis
Conditions:
Lupus Nephritis Lupus Nephritis - World Health Organization (WHO) Class III Lupus Nephritis - WHO Class IV
Study Start (Actual) 2023-04-28
Primary Completion (Estimated) 2025-08
Study Completion (Estimated) 2026-08
Enrollment (Estimated) 32
Study Type INTERVENTIONAL
Phase PHASE1
Locations:
📍 Palo Alto, California, United States
📍 Denver, Colorado, United States
📍 Worcester, Massachusetts, United States
📍 Great Neck, New York, United States
📍 Columbus, Ohio, United States
📍 Philadelphia, Pennsylvania, United States

Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted2022-10-11
  • First Submitted that Met QC Criteria2023-07-07
  • First Posted2023-07-10

Study Record Updates

  • Last Update Submitted that Met QC Criteria2024-07-11
  • Last Update Posted2024-07-12
  • Last Verified2024-07