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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGIncidence of Dose-Limiting Toxicity (DLT)
To characterize the safety of CD19 CAR NK Cells (KN5501) for refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA)
Time frame: up to 52 weeks after infusion
Incidence of Treatment Emergent Adverse Events (TEAEs)
To characterize the safety of CD19 CAR NK Cells (KN5501) for refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA)
Time frame: up to 52 weeks after infusion
The overall response rate (ORR)
To characterize the efficacy of CD19 CAR NK Cell (KN5501) for refractory antisynthetase antibody syndrome (ASyS) and rheumatoid arthritis (RA)
Time frame: 4, 12, 24, 36 and 52 months after infusion
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