Digestive Tract Cancer Clinical Trial
Official title:
Clinical Study on the Safety and Initial Efficacy of BGT007H Cell Therapy in Patients With Recurrent/Metastatic Refractory Digestive Tract Tumors
This is an exploratory clinical study evaluating the safety and initial efficacy of BGT007H injection in the treatment of recurrent/metastatic/refractory digestive system tumors.
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 BGT007H cells were set with 5 dose groups that were gradually increased for treatment evaluation. The dose groups were 2.0 × 10^8cells，5.0 × 10^8cells，1.0 × 10^9cells，3.0 × 10^9cells，6.0 × 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). ;