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
BioSyngen Pte Ltd
14 participants
Oct 9, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
1.0×10\^8cells,Intravenous infusion，1 subject is planned to be enrolled
3.0×10\^8cells,Intravenous infusion，3 subject is planned to be enrolled
1.0×10\^9cells,Intravenous infusion，3 subject is planned to be enrolled
3.0×10\^9cells,Intravenous infusion，3 subject is planned to be enrolled
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06152757