The aim of this study is to investigate the safety and preliminary efficacy of EBV CAR-T cells in the treatment of relapsed/refractory NPC
The investigators designed a single-arm, open-label, "3+3" dose-escalation exploratory study. According to the subject and dose escalation test, the maximum dose or the best effective dose was determined to verify the safe and effective number of cells per body weight. A "3+3" dose escalation design was used to set three dose groups of gradually increasing CAR-T cells for therapeutic evaluation. The dose groups were 3.0×10\^6cells/kg, 9.0×10\^6cells/kg and 1.5×10\^7cells/kg, respectively. Cell reinfusion will take place 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
24
intravenously once, and the dose group was 3.0 × 10\^6cells/kg、9.0 × 10\^6cells/kg、1.5 × 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 CAR-T cell injection , as specified in the protocol
Time frame: From day 0 to day 28
Cmax
The amplification of CAR-T cells in peripheral blood peaked after administration
Time frame: 12 months
Tmax
Number of days of peak CAR-T cell expansion after administration
Time frame: 12 months
AUC(Day 0 to Day 28)
The area under the curve of CAR-T cells from day 0 to day 28 after administration was plotted by the visit time of CAR-T cells in peripheral blood
Time frame: From day 0 to day 28
ORR
Proportion of patients who achieved pre-defined tumor volume change 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 OS
The time between leukocyte apheresis and death from any cause
Time frame: 12 months
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