Actively Recruiting
Study of Anti-CD19 CAR NK Cell Treatment for Adults with Refractory Antisynthetase Syndrome and Rheumatoid Arthritis
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-04-30
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of anti CD19 CAR NK cells KN5501 in patients with refractory antisynthetase antibody syndrome ASyS and rheumatoid arthritis RA. This early phase 1 study aims to determine if KN5501 can clear CD19-positive B cells and assess its expansion and persistence in these patients, who have not responded well to other treatments. Participants will receive three infusions of anti CD19 CAR NK cells following lymphodepletion with fludarabine and cyclophosphamide. The study uses a dose-escalation design conducted at a single center in an open-label format. All subjects will undergo the same treatment regimen and be closely monitored throughout the trial. During the study, participants will be evaluated for treatment safety, including dose-limiting toxicities and adverse events for up to 52 weeks after infusion. Researchers will also measure overall response rates at multiple time points up to 52 months post-infusion. Assessments will include heart function tests, laboratory tests for liver and kidney function, and physical evaluations, with a total follow-up extending over several years to track treatment effects and safety.
CONDITIONS
Brief Title
An Exploratory Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Antisynthetase Antibody Syndrome and Rheumatoid Arthritis
Research Team
W
Wenfeng Tan, PhD, MD
H
Hanxiao You, PhD, MD
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