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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06885710

Enrollment

Registered

2025-03-20

Start date

2024-12-31

Completion date

2028-12-01

Last updated

2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis b

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

Interventions

BIOLOGICALLioCyx-M

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Assessments of adverse events	Start of treatment until 28 days post last dose	To evaluate the safety of LioCyx-M

Secondary

Measure	Time frame	Description
Changes in HBeAb levels	Up to 1 year after last dose	To evaluate the anti-viral efficacy of LioCyx-M
Changes in HBsAg levels	Up to 1 year after last dose	To evaluate the anti-viral efficacy of LioCyx-M
Changes in HBeAg levels	Up to 1 year after last dose	To evaluate the anti-viral efficacy of LioCyx-M

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026