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

Inclusion Criteria:

• CHB infection (Serum HBsAg-positive for ≥ 6 months)

• Serum HBeAg-positive or negative

• HLA class 1 profile matching HLA-class I restriction element of the available T cellreceptors (restricted by either HLA-A02:01, A11:01 or A*24:02).

• Liver biopsy, Fibroscan or equivalent test obtained within the past 6 monthsdemonstrating liver disease consistent with chronic HBV infection without evidenceof 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 ofdecompensated liver function like ascites and varices

• Positive HIV test result

• History or suspected diagnosis of hepatocellular carcinoma, or AFP at screening > 20ng/mL (if AFP > 20 ng/mL, a liver scan result is required to exclude hepatocellularcarcinoma)