Back to results"Treatment of Active HBV With γδT Cells" Clinical Trial Protocol
Primary Purpose
Adoptive Treatment for Hepatitis B With γδT Cells
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Adoptive transfer of γδT cells
Sponsored by
About this trial
This is an interventional treatment trial for Adoptive Treatment for Hepatitis B With γδT Cells focused on measuring HBV infection,γδT cells,Adoptive treatment
Eligibility Criteria
Inclusion Criteria:
- 1. Aged 18-45 years old, male or female; 2. Informed consent; 3. Patient who were tested HBsAg and HBeAg positive; 4. HBV DNA loads>1 million copy/ml;5. Liver function test alanine aminotransferase (ALT) 160 IU/L≤400 IU/L; 6. No jaundice, total bilirubin is normal;7. For patients with new onset, oral antiviral drugs limited for Sebivo.
Exclusion Criteria:
- 1. Pregnant women;2. Patients Complicated with other viruses, bacteria infections and other infectious diseases;3. With other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system disease, mental illness, neurological disease, vascular circulation system diseases and so on, and after clinical doctors diagnose, evaluate the immune cells are not suitable for treatment of patients;4. There is no immediate relatives, immediate family members suffering from infectious diseases including e antigen positive, or immediate family is not suitable for patients as white blood cells supplier;5. Other indications that is not suitable for the treatment
Sites / Locations
- Guagnzhou Qiaokang Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study group
Arm Description
Outcomes
Primary Outcome Measures
DNA copy number
Whether or not the DNA copy number in patients can be lowered more faster than those do not received T cell treatment in 6 months.
Negative conversion rate of HbeAg
We will evaluate whether or not γδT Cells treatment could speed up Negative conversion rate of HbeAg.
Secondary Outcome Measures
Full Information
NCT ID
NCT03113058
First Posted
April 10, 2017
Last Updated
April 19, 2017
Sponsor
Jinan University Guangzhou
Collaborators
Guagnzhou Qiaokang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03113058
Brief Title
"Treatment of Active HBV With γδT Cells" Clinical Trial Protocol
Official Title
"Treatment of HBeAg-positive Chronic Hepatitis B With γδT Cells" Clinical Trial Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2017 (Anticipated)
Primary Completion Date
October 5, 2018 (Anticipated)
Study Completion Date
November 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinan University Guangzhou
Collaborators
Guagnzhou Qiaokang Hospital
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
To evaluate the safety and anti-HBV efficacy of γδT cells.
Detailed Description
In this clinical trial, we will thoroughly evaluate the safety of in vitro expanded γδT cells, including allogeneic originated γδT cells, in clinical treatment of active HBV. At the same time, we will carefully and thoroughly examine and evaluate the clinical efficacy of γδT cells against active HBV, including lowering speed of DNA copy number, and the transferring rate of HBeAg from positive to negative.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adoptive Treatment for Hepatitis B With γδT Cells
Keywords
HBV infection,γδT cells,Adoptive treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
Adoptive transfer of γδT cells
Intervention Description
Patients are treated via intravenous infusion of in vitro-activated allogeneic γδ Tcells every two weeks, 12 times in total (6 months).
Primary Outcome Measure Information:
Title
DNA copy number
Description
Whether or not the DNA copy number in patients can be lowered more faster than those do not received T cell treatment in 6 months.
Time Frame
6 months
Title
Negative conversion rate of HbeAg
Description
We will evaluate whether or not γδT Cells treatment could speed up Negative conversion rate of HbeAg.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Aged 18-45 years old, male or female; 2. Informed consent; 3. Patient who were tested HBsAg and HBeAg positive; 4. HBV DNA loads>1 million copy/ml;5. Liver function test alanine aminotransferase (ALT) 160 IU/L≤400 IU/L; 6. No jaundice, total bilirubin is normal;7. For patients with new onset, oral antiviral drugs limited for Sebivo.
Exclusion Criteria:
1. Pregnant women;2. Patients Complicated with other viruses, bacteria infections and other infectious diseases;3. With other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system disease, mental illness, neurological disease, vascular circulation system diseases and so on, and after clinical doctors diagnose, evaluate the immune cells are not suitable for treatment of patients;4. There is no immediate relatives, immediate family members suffering from infectious diseases including e antigen positive, or immediate family is not suitable for patients as white blood cells supplier;5. Other indications that is not suitable for the treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhinan Yin, Ph.D.
Phone
(+86)18818801179
Email
zhinan.yin@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yangzhe Wu, Ph.D.
Phone
(+86)18826469480
Email
190374157@qq.com
Facility Information:
Facility Name
Guagnzhou Qiaokang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ren X Lai, bachelor
Phone
+86-15920368701
Email
huitou_2007@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
"Treatment of Active HBV With γδT Cells" Clinical Trial Protocol
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