Safety and Efficacy of γδ T Cell Against Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

γδ T Cell Immunotherapy for Treatment of Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02585908
• Other study ID #: Doing-001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 2019
• Est. completion date: December 2022

Study information

• Verified date: September 2019
• Source: Beijing Doing Biomedical Co., Ltd.
• Contact: xie yanyun, master
• Phone: 086-15601041145
• Email: yanyun_xie[@]doingtimes.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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: ?,?,?

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Biological:
• CIK
CIK cells will be used against tumor cells.
• ?d T
?d T cells will be used against tumor cells.
• CIK and ?d T
CIK and ?d T cells will be used against tumor cells.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Hangzhou Cancer Hospital	Hangzhou	Zhejiang
China	Huai'An First People'S Hospital	Huaian	Jiangsu
China	First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Doing Biomedical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced size of the tumor.	Tumor load will be evaluated by RECIST criteria.	up to one year
Secondary	Safety, as measured by the rate of adverse events and serious adverse events	Safety, as measured by the rate of adverse events and serious adverse events	up to two years