NCT06104241

BGT007 Cells for the Treatment of Refractory Digestive System Tumors

Clinical Study on the Safety and Initial Efficacy of BGT007 Cell Therapy in Patients With Recurrent/Metastatic Refractory Digestive Tract Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Gastrointestinal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BGT007 Injection	BGT007 injection (d0) were infused intravenously once, and the dose group was 5.0× 10\^7 cells,1.0 ×10\^8 cells, 3.0× 10\^8 cells,1.0 × 10\^9 cells,3.0 ×10\^9 cells.

Timeline

• Start date: 2023-10-22
• Primary completion: 2026-10-20
• Completion: 2027-10-20
• First posted: 2023-10-27
• Last updated: 2023-10-27

Locations

1 site across 1 country: China