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Clinical Trial Summary

To study the safety and effectiveness of cord blood-derived CAR-NK cells targeting CD19 in patients with B-cell non-Hodgkin's lymphoma


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT05472558
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Wenbin Qian
Phone +8613605801032
Email qianwb@zju.edu.cn
Status Recruiting
Phase Phase 1
Start date September 10, 2022
Completion date September 10, 2025

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