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Clinical Trial Summary

The aim of this study is to investigate the safety and preliminary efficacy of EBV CAR-T cells in the treatment of relapsed/refractory NPC


Clinical Trial Description

The investigators designed a single-arm, open-label, "3+3" dose-escalation exploratory study. According to the subject and dose escalation test, the maximum dose or the best effective dose was determined to verify the safe and effective number of cells per body weight. A "3+3" dose escalation design was used to set three dose groups of gradually increasing CAR-T cells for therapeutic evaluation. The dose groups were 3.0×10^6cells/kg, 9.0×10^6cells/kg and 1.5×10^7cells/kg, respectively. Cell reinfusion will take place on day 0 (d0) and each subject will be observed for at least 4 weeks after receiving cell reinfusion (DLT observation period). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05654077
Study type Interventional
Source The Affiliated Hospital of Xuzhou Medical University
Contact
Status Recruiting
Phase Early Phase 1
Start date January 18, 2022
Completion date December 30, 2025

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