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临床试验/NCT02496273
NCT02496273进行中(未招募)1 期

Phase 1 Study of CEA Specific Cytotoxic T Lymphocytes Induced by Dendritic Cells Infected by Recombinant Adeno-associated Virus With CEA Gene in Stage IV Gastric Cancer

The First People's Hospital of Changzhou0 个研究点目标入组 60 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
60
主要终点
ELISPOT assays

研究概览

简要总结

The purpose of this study is to evaluate the clinical safety and preliminary efficacy of CEA specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.

详细描述

Carcinoembryonic antigen (CEA) describes a set of highly related glycoproteins involved in cell adhesion.CEA is normally produced in gastrointestinal tissue during fetal development, but the production stops before birth. The serum levels are raised in some types of cancer,such as Gastric Cancer.The expression of CEA in these cancers and succedent unfavourable prognosis such as tumor hyperplasia, recurrence make CEA become the desirable therapeutic target.

Cancer immunotherapy is the use of the immune system to treat cancer. Immunotherapies fall into three main groups: cellular, antibody and cytokine.Cellular therapies involve the removal of immune cells from the blood or from a tumor. Immune cells specific for the tumor are activated, cultured and returned to the patient where the immune cells attack the cancer. Cytotoxic T cells and dendritic cells can be used in cell-based immunotherapy.

This study is for patients that have a stage Ⅳ gastric cancer with elevated serum CEA concentration. This research study uses special immune system cells called CEA-specific cytotoxic T lymphocytes , a new experimental therapy.

Blood will be collected from the patient and the CEA-specific CTLs will be made.The cells will be injected by IV into the patient.The investigators will follow the patient from their last infusion,monitor side effects of immunotherapy and learn more about the way the T cells are working in the patient's body.The investigators will use blood samples to see how long the T cells last and to look at the immune response to the patient's response to cancer.

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

入选标准

  • Any patient, at least 18 yrs old regardless of sex, with a diagnosis of Stage IV Gastric Cancer
  • Patients with life expectancy greater than or equal to 6 weeks.
  • Patients with a Karnofsky score of greater than or equal to
  • serum CEA ≥ 20ng/ml.
  • Patient provides consent for all required biopsies.

排除标准

  • Patients with severe active infection.
  • Patients receiving systemic corticosteroid within 48 hours of CTL infusion.
  • Patients with HBV,HCV,HIV infection.

结局指标

主要结局

ELISPOT assays

时间窗: 1 month

Enzyme-Linked ImmunoSpot (ELISPOT) assay is used for monitoring CEA specific cellular immune responses in Gastric Cancer

次要结局

  • overall survival (OS)(1 month)

研究者

申办方类型
Other
责任方
Sponsor

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