A Study of Specific HCC Antigens CD8+ T Cells Therapy for Treating Patients With Relapsed/Advanced Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety]
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Patients with relapsed/advanced HCC (BCLC, stage C) proved by histopathology or proved by CT or MRI imaging system, proven GPC3/NY-ESO-1/AFP(+), relapsed after previous therapy and no effective therapies known at this time.
- •Life expectancy of ≥ 12 weeks.
- •WBC>3.5×10^9/L, LYMPH> 0.8×10^9/L, Hb>85g/L, PLT>50×10^9/L, Cre<1.5×the upper limit of normal value.
- •Able to understand and sign the informed consent.
排除标准
- •Any uncontrolled systematic disease: hypertension, heart disease, and et al.;
- •Portal vein tumor thrombus, central nervous system tumor metastasis, or combined with other tumors;
- •Receiving radiochemotherapy, local therapy, or targeting drugs within 4 weeks prior to this treatment;
- •Unstable immune systematic diseases or Infectious diseases;
- •Combined with AIDS or syphilis;
- •Patients with history of stem cell or organ transplantation;
- •Patients with allergic history to related drugs and immunotherapy;
- •Patients with complications associated with liver diseases: moderate or severe pleural effusion, pericardial effusion, ascites, or gastrointestinal hemorrhage;
- •Pregnant or lactating subjects;
- •Unsuitable subjects considered by clinicians.
研究组 & 干预措施
Autologous T cell therapy+Tegafur+Interleukin-2 (IL-2)
Autologous in vitro expanded HCC antigens-specific CD8+ T lymphocytes in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with relapsed/advanced HCC.
干预措施: HCC antigens-specific CD8+ T lymphocytes (Biological)
Autologous T cell therapy+Tegafur+Interleukin-2 (IL-2)
Autologous in vitro expanded HCC antigens-specific CD8+ T lymphocytes in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with relapsed/advanced HCC.
干预措施: IL-2 (Drug)
Autologous T cell therapy+Tegafur+Interleukin-2 (IL-2)
Autologous in vitro expanded HCC antigens-specific CD8+ T lymphocytes in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with relapsed/advanced HCC.
干预措施: Tegafur (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety]
时间窗: 4 weeks
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.
次要结局
- Biological activity of infused T cells(4 weeks)
研究者
LU JUN
Director of Hepatology and Cancer Biotherapy Ward
Beijing YouAn Hospital