This is an exploratory study to evaluate the safety and preliminary effectiveness of BGT007 cells in the treatment of recurrent/metastatic nasopharyngeal carcinoma
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 BGT007 cells were set with 5 dose groups that were gradually increased for treatment evaluation. The dose groups were 5.0 × 10\^5cells/kg,1.0 × 10\^6cells/kg,3.0 × 10\^6cells/kg,6.0 × 10\^6cells/kg,1.0 × 10\^7cells/kg。 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
23
BGT007 cells (d0) were infused intravenously once, and the dose group was 5.0 × 10\^5cells/kg,1.0 × 10\^6cells/kg,3.0 × 10\^6cells/kg,6.0 × 10\^6cells/kg,1.0 × 10\^7cells/kg。
Fludarabine 25\~30mg/m2/d was infused intravenously for 3 consecutive days. (- 5 days to - 3 days)
250\~350mg/m2/d cyclophosphamide was infused intravenously for 3 consecutive days. (- 5 days to - 3 days)
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 BGT007 cell injection , as specified in the protocol
Time frame: From day 0 to day 28
Cmax
The amplification of BGT007 cells in peripheral blood peaked after administration
Time frame: 12 months
Tmax
Number of days of peak BGT007 cell expansion after administration
Time frame: 12 months
AUC(Day 0 to Day 28)
The area under the curve of BGT007 cells from day 0 to day 28 after administration was plotted by the visit time of BGT007 cells in peripheral blood
Time frame: From day 0 to day 28
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
OS
The time between leukocyte apheresis and death from any cause.
Time frame: 12 months
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