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Clinical Trial Summary

To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed/refractory autoimmune diseases


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 patients after infusion. 8-24 patients are planned to be enrolled in the dose-escalation trial and 12-24 patients in the dose-expansion trial. The primary endpoints are DLT, MTD, and the incidence of abnormalities in AE/SAE/AESI/laboratory test. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06316076
Study type Interventional
Source RenJi Hospital
Contact Qiong Fu, MD, PhD
Phone +086-13585603288
Email fuqiong@renji.com
Status Recruiting
Phase Phase 1
Start date October 30, 2023
Completion date June 2026

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