Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
NCT06885710

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

Led by Changhai Hospital · Updated on 2025-07-17

19

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

Sponsors

C

Changhai Hospital

Lead Sponsor

G

Guangzhou Lion TCR Co Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 receptor (TCR) in combination with nucleos(t)ide analogues (NAs) in HBeAg-positive and negative chronic hepatitis B patients.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chronic Hepatitis B infection confirmed by serum HBsAg positive for 6 months or more
  • Serum HBeAg positive or negative
  • HLA class 1 profile matching HLA-class I restriction elements (HLA-A02:01, A11:01 or A*24:02)
  • Liver biopsy, Fibroscan, or equivalent test within past 6 months showing liver disease consistent with chronic HBV infection without bridging fibrosis or cirrhosis (Metavir stage less than 3)
Not Eligible

You will not qualify if you...

  • History or evidence of other chronic liver diseases unrelated to HBV (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 like ascites and varices
  • Positive HIV test
  • History or suspected hepatocellular carcinoma, or AFP greater than 20 ng/mL at screening without liver scan to exclude cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Changhai Hospital

Shanghai, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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