HBV-Specific TCR-T Cell Therapy Combined with Nucleos(t)ide Analogues in Chronic Hepatitis B Patients

Launched by CHANGHAI HOSPITAL · Mar 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with chronic Hepatitis B, a viral infection that affects the liver. The treatment combines modified T-cells—specialized immune cells that have been engineered to specifically target the Hepatitis B virus—with antiviral medications called nucleos(t)ide analogues. The goal is to see if this combination is safe and effective for people who have a specific type of chronic Hepatitis B infection, known as HBeAg-positive.

To participate in this trial, individuals must be between 18 and 75 years old and have been diagnosed with chronic Hepatitis B for at least six months. They also need to meet certain health criteria, including having a specific genetic profile and evidence of liver disease that is related to Hepatitis B but without severe liver damage. Participants in the trial will receive the new treatment and will be monitored closely to track its effects. This study is currently recruiting, and it aims to help develop better options for managing this long-term liver condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • CHB infection (Serum HBsAg-positive for ≥ 6 months)
• • Serum HBeAg-positive
• • HLA class 1 profile matching HLA-class I restriction element of the available T cell receptors (restricted by either HLA-A\*02:01, A\*11:01 or A\*24:02).
• • Liver biopsy, Fibroscan or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis (≥Metavir 3).
• Exclusion Criteria:
• • History or other evidence of chronic liver disease unrelated to HBV infection (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, non-alcoholic fatty liver disease)
• • Decompensated liver function, such as Child-Pugh grade B or C, or clinical signs of decompensated liver function like ascites and varices
• • Positive HIV test result
• • History or suspected diagnosis of hepatocellular carcinoma, or AFP at screening \> 20 ng/mL (if AFP \> 20 ng/mL, a liver scan result is required to exclude hepatocellular carcinoma)