Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Recurrence

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

1.0×10\^8cells,Intravenous infusion，1 subject is planned to be enrolled

First dose

3.0×10\^8cells,Intravenous infusion，3 subject is planned to be enrolled

Second dose

1.0×10\^9cells,Intravenous infusion，3 subject is planned to be enrolled

The third dose

3.0×10\^9cells,Intravenous infusion，3 subject is planned to be enrolled

The fourth dose

Xinfeng Chen

Dan Wang

Yi Zhang

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.

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

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

Incidence of adverse events defined as Dose-Limiting Toxicity (DLT).

The maximum CAR-T dose that can be tolerated in the study.

The incidence of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), cytokine release syndrome (CRS) immune cell associated neurotoxicity syndrome (ICANS) and treatment-emergent adverse events (TEAE).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors	NCT06152757	Gastrointestina...	First dose Second dose The third dose The fourth dose	18 Years -	BioSyngen Pte Ltd
BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors	NCT06152757	Gastrointestina...	First dose Second dose The third dose The fourth dose	18 Years -	BioSyngen Pte Ltd

Spots Global Cancer Trial Database for the third dose