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Clinical Trial Summary

This study is designed to monitor all patients exposed to CD19 CAR-T expressing IL7 and CCL19 for 5 years following infusion, to assess their long-term efficacy, including the CAR-vector persistence, the normal immunity rebuilding and the risk of delayed adverse events (AEs).


Clinical Trial Description

Patients are enrolled following completion from the early clinical study of CD19-7X19 CAR-T treatment ( NCT03258047) and will be followed for 5 years post treatment from the last treatment. They will be monitored for safety and efficacy with the primary treatment protocols for the protocol defined duration. This long-term following up study allow an interim analysis to evaluate the outcomes of the study when it arrives in 2 years Collection of such long term effects of CAR-T cell therapy will help to further define the risk-benefit profile of CAR-T Therapies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04833504
Study type Observational [Patient Registry]
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact
Status Completed
Phase
Start date July 1, 2018
Completion date October 1, 2020

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