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NCT Number: NCT06885710

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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)

Treatment and study plan

LioCyx-M

Biological

Each patient will receive LioCyx-M infusion every one or two weeks, while continuing their existing nucleos(t)ide analog treatment.

Primary outcomes

  1. Assessments of adverse events

    Time frame: Start of treatment until 28 days post last dose

    To evaluate the safety of LioCyx-M

Secondary outcomes

  1. Changes in HBeAg levels

    Time frame: Up to 1 year after last dose

    To evaluate the anti-viral efficacy of LioCyx-M

  2. Changes in HBeAb levels

    Time frame: Up to 1 year after last dose

    To evaluate the anti-viral efficacy of LioCyx-M

  3. Changes in HBsAg levels

    Time frame: Up to 1 year after last dose

    To evaluate the anti-viral efficacy of LioCyx-M

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • Guangzhou Lion TCR Co Ltd

Registry information

Official study title

Safety and Efficacy of Hepatitis B Virus (HBV)-Specific T Cell Receptor (TCR)-T Cell Therapy Combined With Nucleos(t)Ide Analogues (NAs) in HBeAg-Positive Chronic Hepatitis B Patients

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 20, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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