Safety and Efficacy of γδ T Cell Against Gastric Cancer

Phase 1

• Conditions: Gastric Cancer
• Interventions: Biological: CIK; Biological: γδ T; Biological: CIK and γδ T

• Registration Number: NCT02585908
• Lead Sponsor: Beijing Doing Biomedical Co., Ltd.

Brief Summary

In this study, safety and effects of γδT cells on human gastric cancer are going to be investigated.

Detailed Description

PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and CIK, they will be infused to the patients as immunotherapy.

Study Timeline

• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-26
• Status Verified: 2019-09
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-13
• Study Start: 2019-12
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age:30-75
2. Karnofsky performance status >50
3. Diagnosis with gastric cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Patients who have a life expectancy of at least 12 weeks
6. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria

1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
2. Known human immunodeficiency virus (HIV) infection.
3. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
4. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
5. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group B	CIK	CIK will be used against tumor cells.
Experimental Group C	γδ T	γδ T will be used against tumor cells.
Experimental Group D	CIK and γδ T	CIK and γδ T will be used against tumor cells.

Primary Outcome Measures

Name	Time	Method
Reduced size of the tumor.	up to one year	Tumor load will be evaluated by RECIST criteria.

Secondary Outcome Measures

Name	Time	Method
Safety, as measured by the rate of adverse events and serious adverse events	up to two years	Safety, as measured by the rate of adverse events and serious adverse events

Trial Locations

Locations (4)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Hangzhou Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

First Affiliated Hospital of Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China

Huai'An First People'S Hospital; 🇨🇳 Huaian, Jiangsu, China