To study the safety and efficacy of cord blood-derived CAR-NK cells targeting CD19/CD70 in patients with B-cell non-Hodgkin's lymphoma
This is a single-center, open, one-arm, dose-escalation study to observe the safety and efficacy of cord blood-derived dualCAR-NK19/70 cells in patients with B-cell non-Hodgkin lymphoma.9-18 patients are planned to be enrolled in the dose-escalation trial (2×10\^6 cells/kg, 4×10\^6 cells/kg, 8×10\^6 cells/kg) . Each dose was given once a week for 3 weeks.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/CD70 CAR and IL15
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
Overall survival (OS)
To determine the anti-tumor effectivity of CB dualCAR-NK19/70
Time frame: Up to 2 years
Overall response rate (ORR)
To determine the anti-tumor effectivity of CB dualCAR-NK19/70
Time frame: Up to 2 years
Duration of response (DOR)
To determine the anti-tumor effectivity of CB dualCAR-NK19/70
Time frame: Up to 2 years
Complete response rate (CR)
To determine the anti-tumor effectivity of CB dualCAR-NK19/70
Time frame: Up to 2 years
Partial response rate (PR)
To determine the anti-tumor effectivity of CB dualCAR-NK19/70
Time frame: Up to 2 years
Progression free survival (PFS)
To determine the anti-tumor effectivity of CB dualCAR-NK19/70
Time frame: Up to 2 years
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