Clinical Study of ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Advanced Liver Cancer
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Frequency of ARTEMIS T cell treatment-related adverse events
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ET 140202 -T cell combined With TAE or Sorafenib in the treatment of liver cancer
详细描述
The molecular target for ET140202-T cells is HLA-A02 complexed with a HLA-A02-restricted peptide of alpha fetoprotein (AFP), which is expressed on 60-80 percent of hepatocellular carcinoma (HCC). This clinical study evaluates the safety and pharmacokinetics of ET140202-T cells with TAE or Sorafenib in patients with HCC who have no available curative therapeutic options and a poor overall prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AFP-expressing HCC and serum AFP >10 x ULN
- •Abandon or failure in first or second line treatment
- •Molecular HLA class I typing confirms participant carries at least one HLA-A02 allele
- •Child-Pugh score of A or B, ECOG 0-2, Life expectancy > 6 months
- •Measurable disease as defined by: at least 1 liver lesion that can be accurately and serially measured.
- •Negative serum pregnancy test for women with childbearing potential
- •Adequate organ function as defined below:
- •A pretreatment measured creatinine clearance (absolute value) of ≥50 ml/minute.
- •Patients must have a serum direct bilirubin ≤3 x ULN, ALT and AST ≤5 x ULN.
- •Ejection Fraction measured by echocardiogram or MUGA >50% (evaluation done within 6 weeks of screening does not need to be repeated)
- •DLCO or FEV1 >45% predicted
- •Absolute neutrophil count (ANC) ≥ 1500/mm3 (10^9/L), Platelet count ≥ 50,000/mm3 (10^9/L)
- •INR ≤1.5 x ULN
- •Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.
排除标准
- •Patients with decompensated cirrhosis: Child-Pugh Score C
- •Patients with tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver.
- •Patients with an organ transplantation history
- •Patients with dependence on corticosteroids
- •Patients with active autoimmune diseases requiring systemic immunosuppressive therapy
- •Patients who are currently receiving or received within past 30 days anti-cancer therapy, local treatments for liver tumors (radiotherapy, embolism, ablation) or liver surgery
- •Patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy)
- •Participants with other active malignancies (except non-melanoma skin cancer and cervical cancer) within two years. Patients with a history of successfully-treated tumors with no sign of recurrence in the last two years may be enrolled.
- •Patients with other uncontrolled diseases, such as active infections Acute or chronic active hepatitis B or hepatitis C.
- •Women who are pregnant or breast-feed
- •HIV-infection
研究组 & 干预措施
ET140202-T cell combine with Sorafenib
Sorafenib treatment everyday and autologous ET140202-T cell administered by intravenous (IV) infusion
干预措施: Sorafenib combined with ET140202-T cell (Combination Product)
ET140202-T cell combine with TAE
TAE treatment ahead every two times of autologous ET140202-T cell administered by intravenous (IV) infusion
干预措施: TAE combined with ET140202-T cell (Combination Product)
solo ET140202-T cell
autologous ET140202-T cell administered by intravenous (IV) infusion
干预措施: ET140202-T cell (Biological)
结局指标
主要结局
Frequency of ARTEMIS T cell treatment-related adverse events
时间窗: 28 days up to 2 years
Include but not limited to: Fever, chills, nausea, vomiting, jaundice and other gastrointestinal symptoms; Fatigue, hypotension, respiratory distress; Tumor lysis syndrome; Cytokine release syndrome; Neutropenia, thrombocytopenia; Liver and kidney dysfunction. Assessed at all visits.
次要结局
- IL-6 serum levels(4-8 weeks)
- Overall survival（OS）(at 2 years)
- IL-2 serum levels(4-8 weeks)
- IL-10 serum levels(4-8 weeks)
- AFP serum levels(2 years)
- Alpha-fetoprotein (AFP) expression in tumors(4-8 weeks)
- Rate of disease response by RECIST at non-liver sites(2 years)
- Median Survival（MS）(at 4 months, 1 year, 2 years)
- Progression free survival (PFS)(at 4 months, 1 year, 2 years)
- Number of ET140202-T cells in peripheral blood(2 years)
- TNF-α serum levels(4-8 weeks)
- IFN-γ serum levels(4-8 weeks)
- Rate of disease response by RECIST in the liver(2 years)