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RECRUITING
NCT06152757
EARLY_PHASE1

BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors

Sponsor: BioSyngen Pte Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2023-10-09

Completion Date

2027-07-19

Last Updated

2023-12-01

Healthy Volunteers

No

Interventions

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

Locations (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China