Phase I Trial of CEA Specific AAV-DC-CTL Treatment in Stage IV Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02496273
Recruitment Status : Active, not recruiting
First Posted : July 14, 2015
Last Update Posted : February 22, 2016
Information provided by (Responsible Party):
The First People's Hospital of Changzhou

July 9, 2015
July 14, 2015
February 22, 2016
January 2016
December 2026   (Final data collection date for primary outcome measure)
ELISPOT assays [ Time Frame: 1 month ]
Enzyme-Linked ImmunoSpot (ELISPOT) assay is used for monitoring CEA specific cellular immune responses in Gastric Cancer
Same as current
Complete list of historical versions of study NCT02496273 on Archive Site
overall survival (OS) [ Time Frame: 1 month ]
Same as current
Not Provided
Not Provided
Phase I Trial of CEA Specific AAV-DC-CTL Treatment in Stage IV Gastric Cancer
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 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.

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.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastric Cancer
Biological: CTL
Mononuclear cells (Dendritic Cell,DC precursor) were isolated from the peripheral blood of gasric cancer by density gradient centrifugation and infected with rAAV/CEA virus.Maturation of the DC was induced by granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-4 (IL-4) and tumor necrosis factor-alpha(TNF-alpha). On day 7, the DCs were collected and mixed with T cells at the ratio of 1 to 20 to induce cytotoxic T lymphocytes (CTL).The cells will be proliferated and infused by intravenous (IV) infusion into the patient.
Other Name: CEA Specific Cytotoxic T-Lymphocytes
Experimental: CEA Specific CTL
Patients receiving CEA-specific CTLs as therapy for Gastric Cancer
Intervention: Biological: CTL

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
December 2030
December 2026   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 80.
  • serum CEA ≥ 20ng/ml.
  • Patient provides consent for all required biopsies.

Exclusion Criteria:

  • Patients with severe active infection.
  • Patients receiving systemic corticosteroid within 48 hours of CTL infusion.
  • Patients with HBV,HCV,HIV infection.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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The First People's Hospital of Changzhou
The First People's Hospital of Changzhou
Not Provided
Study Chair: Wu Changping, M.D The First People's Hospital of Changzhou
The First People's Hospital of Changzhou
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP