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Clinical Study of the Efficacy of CD19-CAR-DNT Cells in the Treatment of Relapsed/Refractory B-cell NHL

B-cell Non-Hodgkin's Lymphoma Clinical Trial

Official title:
Clinical Study of the Efficacy of CD19-CAR-DNT Cells in the Treatment of Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

Clinical Trial Summary

To evaluate the safety and tolerability of CD19-CAR-DNT cells infusion in subjects with relapsed/refractory B-cell non-Hodgkin's Lymphoma

Clinical Trial Description

This is an open, single-arm, single-dose, dose-escalation and dose-expansion clinical trial designed to evaluate the maximum tolerated dose of CD19-CAR-DNT cells, the safety, the preliminary efficacy and the pharmacokinetic profile of CD19-CAR-DNT cells in vivo after infusion in clinical studies. 9 patients are planned to be enrolled in the dose-escalation trial (1×10^6 CD19-CAR-DNT cells/kg, 3×10^6 CD19-CAR-DNT cells/kg, 9×10^6 CD19-CAR-DNT cells/kg) and 3 patients in the dose-expansion trial. The primary endpoints are DLT, MTD, and the incidence of abnormalities in AE/SAE/AESI/laboratory tests/electrocardiograms/vital signs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05453669
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Wenbin Qian, MD, PhD
Phone +8613605801032
Email qianwb@zju.edu.cn
Status Recruiting
Phase Phase 1
Start date June 15, 2022
Completion date June 2025
View Details
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