"Treatment of Active HBV With γδT Cells" Clinical Trial Protocol

Early Phase 1

• Conditions: Adoptive Treatment for Hepatitis B With γδT Cells
• Interventions: Combination Product: Adoptive transfer of γδT cells

• Registration Number: NCT03113058
• Lead Sponsor: Jinan University Guangzhou

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.

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-13
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-21
• Study Start: 2017-05-02
• Primary Completion: 2018-10-05
• Study Completion: 2018-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study group	Adoptive transfer of γδT cells	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Guagnzhou Qiaokang Hospital; 🇨🇳 Guangzhou, Guangdong, China