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

Phase 1

Active, not recruiting

• Conditions: Gastric Cancer
• Interventions: Biological: CTL

• Registration Number: NCT02496273
• Lead Sponsor: The First People's Hospital of Changzhou

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-07-09
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-14
• Study Start: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-19
• Last Update Posted: 2016-02-22
• Primary Completion: 2026-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CEA Specific CTL	CTL	Patients receiving CEA-specific CTLs as therapy for Gastric Cancer

Primary Outcome Measures

Name	Time	Method
ELISPOT assays	1 month	Enzyme-Linked ImmunoSpot (ELISPOT) assay is used for monitoring CEA specific cellular immune responses in Gastric Cancer

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	1 month