Adoptive Treatment for Hepatitis B With γδT Cells
Conditions
Keywords
HBV infection,γδT cells,Adoptive treatment
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.
Interventions
COMBINATION_PRODUCTAdoptive 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).
Sponsors
Guagnzhou Qiaokang Hospital
Jinan University Guangzhou
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactZhinan Yin, Ph.D.
Backup ContactYangzhe Wu, Ph.D.
Outcome results
None listed