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.
Voluntarily sign a written informed consent;
Age ≥18 years old, ≤70 years old, male and female;
Expected survival ≥ 3 months;
The Eastern Cancer Collaboration (ECOG) physical fitness score was 0-1;
Active central nervous system metastases (except those stable after treatment);
HIV positive, HBsAg positive, HBV DNA copy number positive (quantitative detection ≥1000cps/ml), HCV antibody positive and HCV RNA positive;
Patients with mental or mental illness who cannot cooperate with treatment and efficacy evaluation;
Subjects with severe autoimmune diseases and long-term use of immunosuppressants;
Single group
BGT007H Injection
Biological/VaccineBGT007H injection (d0) were infused intravenously once, and the dose group was 2.0× 10\^8 cells,5.0 ×10\^8 cells, 1.0× 10\^9 cells,3.0 × 10\^9 cells,6.0 ×10\^9 cells.
Dose-limiting toxicity（DLT）
Adverse events related to cell therapy were observed on 28 days after BGT007H injection , as specified in the protocol
Cmax
The amplification of BGT007H injection in peripheral blood peaked after administration
Tmax
Number of days of peak BGT007H injection expansion after administration
ORR
Proportion of patients who achieved pre-defined tumor volume reduction and maintained the minimum time limit.Imaging examination was performed after administration, and RECIST1.1 evaluation criteria was used for evaluation.
PFS
The time from the onset of leukocyte apheresis to the appearance of tumor progression or death.
Click on the lead sponsor to view all of their trials.
The Affiliated Hospital of Xuzhou Medical University
Lead sponsor
Guangzhou Bioresette Biomedical Technology Co., Ltd.
Collaborator
