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

Adoptive Treatment for Hepatitis B With ?dT Cells Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03113058
• Other study ID #: GDT-HBV-01-QK
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: April 10, 2017
• Last updated: April 19, 2017
• Start date: May 2, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: April 2017
• Source: Jinan University Guangzhou
• Contact: Zhinan Yin, Ph.D.
• Phone: (+86)18818801179
• Email: zhinan.yin[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 1, 2018
• Est. primary completion date: October 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Adoptive Treatment for Hepatitis B With ?dT Cells
• Hepatitis
• Hepatitis B

Intervention

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

Locations

Country	Name	City	State
China	Guagnzhou Qiaokang Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Jinan University Guangzhou	Guagnzhou Qiaokang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Negative conversion rate of HbeAg	We will evaluate whether or not ?dT Cells treatment could speed up Negative conversion rate of HbeAg.	6 months