Treatment of Active HBV With γδT Cells Clinical Trial Protocol

Study Overview
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Brief Summary
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To evaluate the safety and anti-HBV efficacy of γδT cells.

Detailed Description
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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.

Official Title
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Treatment of HBeAg-positive Chronic Hepatitis B With γδT Cells Clinical Trial Protocol

Conditions
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Adoptive Treatment for Hepatitis B With γδT Cells

Intervention / Treatment
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* Combination Product: Adoptive transfer of γδT cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br> | Combination Product: Adoptive transfer of γδT cells<br>* Patients are treated via intravenous infusion of in vitro-activated allogeneic γδ Tcells every two weeks, 12 times in total (6 months).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| Negative conversion rate of HbeAg | We will evaluate whether or not γδT Cells treatment could speed up Negative conversion rate of HbeAg. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBV infection,γδT cells,Adoptive treatment