This study is a single-arm, open-label, single-administration dose-escalation study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Armored dendritic cells are administered via multiple subcutaneous injections.
Shanghai Mengchao Tumor Hospital
Shanghai, China
RECRUITINGMaximum Tolerated Dose
Time frame: Day 0-Month 5
Evaluate the incidence and severity of adverse events
Adverse events (AEs), serious adverse events (SAEs) and laboratory abnormalities (including their types, frequencies and severity) will be collected. This includes the types, incidence and severity of adverse events, as well as clinically significant abnormal laboratory test results and abnormal physical examination findings that emerge after treatment. Clinical and laboratory adverse events will be primarily graded using Version 6.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). The causal relationship between adverse events and the dendritic cell (DC) product will be assessed by investigators in accordance with the causality evaluation criteria specified in the study protocol.
Time frame: Day 0-Month 24
Cmax
Time frame: day 0-day28
antigen-specific T-cell responses
Time frame: day 0-Month 5
RFS
1- and 2-year recurrence-free survival rates (RFS)
Time frame: day 0-Month 24
Tmax
Time frame: day 0- day 28
Tlast
Time frame: day 0-day 28
concentration of tumor markers
Time frame: day 0-month 5
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