BGT007 Cells for the Treatment of Refractory Digestive System Tumors

Status Recruiting

Clinical Trial Summary

This is an exploratory clinical study evaluating the safety and initial efficacy of BGT007 injection in the treatment of recurrent/metastatic/refractory digestive system tumors

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 × 10^7cells，1.0 × 10^8cells，3.0 × 10^8cells，1.0 × 10^9cells，3.0 × 10^9cells. 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	NCT06104241
Study type	Interventional
Source	The Affiliated Hospital of Xuzhou Medical University
Contact
Status	Recruiting
Phase	Early Phase 1
Start date	October 22, 2023
Completion date	October 20, 2027

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