NCT06152757

BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors

Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent/Refractory Gastrointestinal Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: BioSyngen Pte Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an exploratory single-arm, open, modified "3+3" dose escalation study with BGT007H injection. Approximately 11 to 14 subjects with recurrent/refractory gastrointestinal tumors will be enrolled to evaluate the safety of BGT007H injection. Four dose levels were designed for this study: 1.0×10\^8cells, 3.0×10\^8cells, 1.0×10\^9cells, and 3.0×10\^9cells. The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic profile of BGT007H cell therapy in patients with recurrent/refractory digestive tract tumors, to determine the maximum tolerated dose or the best effective dose, and to initially evaluate the effectiveness of BGT007H cell products.

Detailed description

Main research objectives: Evaluation of the safety and tolerability of BGT007H cell therapy in patients with recurrent/refractory gastrointestinal tumors Secondary research objectives: 1. Evaluate the pharmacokinetic (PK) characteristics of BGT007H cells after reinfusion; 2. Evaluation of the initial effectiveness of BGT007H cell therapy in patients with recurrent/refractory gastrointestinal tumors Exploratory Purpose 1. Exploring the correlation between the proliferation and survival of BGT007H cells in vivo and their therapeutic effects; 2. Exploring the correlation between target expression levels and efficacy

Conditions

• Gastrointestinal Tumors

Interventions

Type	Name	Description
BIOLOGICAL	First dose	1.0×10\^8cells,Intravenous infusion，1 subject is planned to be enrolled
BIOLOGICAL	Second dose	3.0×10\^8cells,Intravenous infusion，3 subject is planned to be enrolled
BIOLOGICAL	The third dose	1.0×10\^9cells,Intravenous infusion，3 subject is planned to be enrolled
BIOLOGICAL	The fourth dose	3.0×10\^9cells,Intravenous infusion，3 subject is planned to be enrolled

Timeline

• Start date: 2023-10-09
• Primary completion: 2025-07-19
• Completion: 2027-07-19
• First posted: 2023-12-01
• Last updated: 2023-12-01

Locations

1 site across 1 country: China