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Safety and Efficacy of γδ T Cell Against Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CIK
γδ T
CIK and γδ T
Sponsored by
Beijing Doing Biomedical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical University
  • First Affiliated Hospital of Henan University of Science and Technology
  • Huai'An First People'S Hospital
  • Hangzhou Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Experimental Group A(control group)

Experimental Group B

Experimental Group C

Experimental Group D

Arm Description

regular treatment and follow up

CIK will be used against tumor cells.

γδ T will be used against tumor cells.

CIK and γδ T will be used against tumor cells.

Outcomes

Primary Outcome Measures

Reduced size of the tumor.
Tumor load will be evaluated by RECIST criteria.

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2015
Last Updated
November 11, 2019
Sponsor
Beijing Doing Biomedical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02585908
Brief Title
Safety and Efficacy of γδ T Cell Against Gastric Cancer
Official Title
γδ T Cell Immunotherapy for Treatment of Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Doing Biomedical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group A(control group)
Arm Type
No Intervention
Arm Description
regular treatment and follow up
Arm Title
Experimental Group B
Arm Type
Experimental
Arm Description
CIK will be used against tumor cells.
Arm Title
Experimental Group C
Arm Type
Experimental
Arm Description
γδ T will be used against tumor cells.
Arm Title
Experimental Group D
Arm Type
Experimental
Arm Description
CIK and γδ T will be used against tumor cells.
Intervention Type
Biological
Intervention Name(s)
CIK
Intervention Description
CIK cells will be used against tumor cells.
Intervention Type
Biological
Intervention Name(s)
γδ T
Intervention Description
γδ T cells will be used against tumor cells.
Intervention Type
Biological
Intervention Name(s)
CIK and γδ T
Intervention Description
CIK and γδ T cells will be used against tumor cells.
Primary Outcome Measure Information:
Title
Reduced size of the tumor.
Description
Tumor load will be evaluated by RECIST criteria.
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
Safety, as measured by the rate of adverse events and serious adverse events
Description
Safety, as measured by the rate of adverse events and serious adverse events
Time Frame
up to two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age:30-75 Karnofsky performance status >50 Diagnosis with gastric cancer based on histology or the current accepted radiological measures. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Patients who have a life expectancy of at least 12 weeks Ability to understand the study protocol and a willingness to sign a written informed consent document Exclusion Criteria: Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. Known human immunodeficiency virus (HIV) infection. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection). Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient. Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xie yanyun, master
Phone
086-15601041145
Email
yanyun_xie@doingtimes.com
First Name & Middle Initial & Last Name or Official Title & Degree
li gangyi, master
Phone
086-13901106501
Email
gangyi_li@doingtimes.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li gangyi, master
Organizational Affiliation
Beijing Doing Biomedical Co., Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Facility Name
Huai'An First People'S Hospital
City
Huaian
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Facility Name
Hangzhou Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310002
Country
China

12. IPD Sharing Statement

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Safety and Efficacy of γδ T Cell Against Gastric Cancer

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