“Treatment of Active HBV With γδT Cells” Clinical Trial Protocol

Overview

To evaluate the safety and anti-HBV efficacy of γδT cells.

Full Title of Study: “”Treatment of HBeAg-positive Chronic Hepatitis B With γδT Cells” Clinical Trial Protocol”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 5, 2018

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.

Interventions

  • Combination Product: Adoptive transfer of γδT cells
    • Patients are treated via intravenous infusion of in vitro-activated allogeneic γδ Tcells every two weeks, 12 times in total (6 months).

Arms, Groups and Cohorts

  • Experimental: study group

Clinical Trial Outcome Measures

Primary Measures

  • DNA copy number
    • Time Frame: 6 months
    • 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
    • Time Frame: 6 months
    • We will evaluate whether or not γδT Cells treatment could speed up Negative conversion rate of HbeAg.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jinan University Guangzhou
  • Collaborator
    • Guagnzhou Qiaokang Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhinan Yin, Ph.D., Principal Investigator – Jinan University Guangzhou
  • Overall Contact(s)
    • Zhinan Yin, Ph.D., (+86)18818801179, zhinan.yin@yale.edu

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