To study the safety and effectiveness of cord blood-derived CAR-NK cells targeting CD19 in patients with B-cell non-Hodgkin's lymphoma
This is an open, single-arm, single-dose, dose-escalation clinical trial designed to evaluate the safety and the preliminary efficacy of CB CAR-NK019 cells. 9-18 patients are planned to be enrolled in the dose-escalation trial (2×10\^6 cells/kg ,3×10\^6 cells/kg, 4×10\^6 cells/kg) . The primary endpoints are DLT, MTD, and the second endpionts are the overall response rates (CR and PR), overall survival, and progression-free survival. Based on the results in the dose-escalation trial, the recommended dose will be determined. Another 30 patients will be enrolled to estimate the safety and efficacy of CB CAR-NK019 under the best dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
lentiviral vector-transducted cord blood-derived NK cells to express anti-CD19 CAR
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, China
RECRUITINGIncidence of dose limiting toxicity (DLTs)
To evaluate the safety, tolerability, and determine the recommended dosage of cord blood-derived Anti-CD19 CAR-NK Cell Therapy for B-cell Non-Hodgkin Lymphoma
Time frame: Up to 28 days
Complete response rate (CR)
To determine the anti-tumor effectivity of CB CAR-NK019
Time frame: Up to 2 years
Progression free survival (PFS)
To determine the anti-tumor effectivity of CB CAR-NK019
Time frame: Up to 2 years
Duration of response (DOR)
To determine the anti-tumor effectivity of CB CAR-NK019
Time frame: Up to 2 years
Overall survival (OS)
To determine the anti-tumor effectivity of CB CAR-NK019
Time frame: Up to 2 years
Partial response rate (PR)
To determine the anti-tumor effectivity of CB CAR-NK019
Time frame: Up to 2 years
Overall response rate (ORR)
To determine the anti-tumor effectivity of CB CAR-NK019
Time frame: Up to 2 years
Immunogenicity after the infusion of CB CAR-NK019
To evaluate the immunogenicity of CB CAR-NK019
Time frame: Up to 2 years
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