Status:
RECRUITING
HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients
Lead Sponsor:
Changhai Hospital
Collaborating Sponsors:
Guangzhou Lion TCR Co Ltd
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a open-label study to evaluate the safety and efficacy of autologous T-cells transfected with messenger ribonucleic acid (mRNA) encoding Hepatitis-B virus (HBV) antigen specific T cell recepto...
Eligibility Criteria
Inclusion
- 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 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
- 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)
Key Trial Info
Start Date :
December 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT06885710
Start Date
December 31 2024
End Date
December 1 2028
Last Update
July 17 2025
Active Locations (1)
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1
Changhai Hospital
Shanghai, China