NCT04677088Unknown1 期
Phase I Study of T Cell Receptor-Redirected T Cells With Recurrent HBV Treatment in Patients-Related Hepatocellular Carcinoma in Post Liver Transplantation
Xiaoshun He1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2018年3月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Safety evaluation of the TCR-T treatment
研究概览
简要总结
This is a single-arm and open-label study to assess the safety, tolerability and primary efficacy of the HBV specific T cell receptor (HBV/TCR) redirected T cell in patients with recurrent Hepatitis B virus (HBV) related hepatocellular carcinoma post liver transplantation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis as hepatocellular carcinoma (HCC).
- •Recurrent locally advanced and/or metastatic hepatocellular carcinoma (HCC) post liver transplantation.
- •Seropositive for hepatitis B surface antigen, or presence of HBV DNA or HBV RNA.
- •HLA profile matching with HLA-class I restriction element of the available T cell receptors.
- •ECOG performance status ≤
- •Laboratory criteria:
- •Liver function: ALT and AST ≤ 5 of upper limit of normal (ULN), TBIL ≤ 3 x ULN.
- •Neutrophil cell number ≥1.5×10^9/L.
- •Platelet count ≥100×10^9/L.
- •Ability to provide informed consent.
- •Willing and able to comply with all study procedures.
排除标准
- •Second primary malignancy that is clinically detectable at the time of consideration for study enrolment.
- •Likelihood to require steroid treatment during the period of the clinical trial.
- •Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •Administration of any other cell therapy, including NK, CIK, DC, CTL, CAR- T, stem cells or combined therapy of the kind within 28 days prior to start of treatment.
- •Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study.
结局指标
主要结局
Safety evaluation of the TCR-T treatment
时间窗: Start of Treatment until 28 days post last dose
Incidence of adverse events/serious adverse events
次要结局
- Overall Response Rate(Start of treatment until disease progression, and subsequent follow up up to 24 months post treatment.)
- Progression-free survival (PFS)(Start of treatment until disease progression, and at 6-month and 1-year.)
- Overall survival (OS)(Start of treatment until disease progression, and at 6-month and 1-year.)
研究者
Xiaoshun He
MD.
First Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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