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

Phase 1

Recruiting

• Conditions: Chronic Hepatitis b
• Interventions: Biological: LioCyx-M

• Registration Number: NCT06885710
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-31
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-14
• Study First Posted: 2025-03-20
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Primary Completion: 2027-12-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 19

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LioCyx-M (Autologous T-cells transfected with mRNA encoding HBV antigen specific TCR)	LioCyx-M	Escalating doses of LioCyx-M from 5×10E05 to 50×10E06 cells/kg body weight (BW), administered every two weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in HBeAg levels	Up to 1 year after last dose	To evaluate the anti-viral efficacy of LioCyx-M
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

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, China