BGT007 Cell Treatment of Nasopharyngeal Carcinoma

Status Recruiting

Clinical Trial Summary

This is an exploratory study to evaluate the safety and preliminary effectiveness of BGT007 cells in the treatment of recurrent/metastatic nasopharyngeal carcinoma

Clinical Trial Description

The researchers designed a single arm, open, exploratory study to improve the "3+3" dose escalation. The maximum dose or the best effective dose shall be determined according to the subject and dose increasing test to verify the safe and effective number of cells per unit weight. The improved "3+3" dose increasing design was adopted, and BGT007 cells were set with 5 dose groups that were gradually increased for treatment evaluation. The dose groups were 5.0 × 10^5cells/kg，1.0 × 10^6cells/kg，3.0 × 10^6cells/kg，6.0 × 10^6cells/kg，1.0 × 10^7cells/kg。 Cell reinfusion will be carried out 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

Clinical Trial Details

NCT number	NCT05616468
Study type	Interventional
Source	The Affiliated Hospital of Xuzhou Medical University
Contact
Status	Recruiting
Phase	Early Phase 1
Start date	December 30, 2022
Completion date	December 31, 2025

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See also
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