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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
BGT007H 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.
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGDose-limiting toxicity(DLT)
Adverse events related to cell therapy were observed on 28 days after BGT007H injection , as specified in the protocol
Time frame: From day 0 to day 28
Cmax
The amplification of BGT007H injection in peripheral blood peaked after administration
Time frame: 12 months
Tmax
Number of days of peak BGT007H injection expansion after administration
Time frame: 12 months
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.
Time frame: 12 months
PFS
The time from the onset of leukocyte apheresis to the appearance of tumor progression or death.
Time frame: 12 months
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