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An Exploratory Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Summary
A single-center, open-label dose-escalation design to evaluate the safety and efficacy of 3 infusions of anti CD19 CAR NK cells (KN5501), as well as the expansion and persistence of KN5501 in patients with refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA); To evaluate the ability of KN5501 to clear CD19-positive B cells in patients to determine the feasibility of KN5501 for the treatment of refractory ASyS and or RA.
Official title: An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-05-20
Completion Date
2026-10-20
Last Updated
2025-04-30
Healthy Volunteers
No
Interventions
anti CD19 CAR NK cells
This study is a single-arm, open-label and single-center exploratory clinical study to evaluate the safety and effectiveness of anti CD19 CAR NK cells in patients with refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA). All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by Anti-CD19 CAR NK cells infusion.
Locations (1)
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China