This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or the patients cannot receive standard treatment under current conditions. This research study uses specific HCC antigens CD8+ T cells, a new experimental treatment. The purpose of this study is to evaluate the safety and tolerance as well as the potential clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with human leukocyte antigen (HLA)-peptide multimers and specific for Glypican (GPC)-3 /New York Esophageal Squamous-1 (NY-ESO-1) /alpha-fetoprotein (AFP) antigens and cultured in vitro, to patients suffering from relapsed/advanced hepatocellular carcinoma (HCC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Three different dosing schedules will be evaluated. Three patients will be evaluated on each dosing schedule. The following dose levels will be evaluated: Loading Dose 1: 3x10\^7/m2 Loading Dose 2: 6x10\^7/m2 Loading Dose 3: 9x10\^7/m2 The doses are calculated according to the actual number of GPC3/NY-ESO-1/AFP specific cytotoxic lymphocytes (CTLs)
IL-2 will be given at a dose of 25000 IU/kg/day for 5-14 days.
Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGIncidence of Treatment-Emergent Adverse Events [Safety]
Defined as signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.
Time frame: 4 weeks
Biological activity of infused T cells
To assess the biological activity of infused in vitro expanded and sorted HCC antigens-specific T cells.
Time frame: 4 weeks
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