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

NCT06885710 | Recruiting Phase 1

• 1 other identifier: LTCR-CHB-1-1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (1)

• Assessments of adverse events

  To evaluate the safety of LioCyx-M

  Start of treatment until 28 days post last dose

Secondary Outcomes (3)

• Changes in HBeAg levels

  Up to 1 year after last dose

• Changes in HBeAb levels

  Up to 1 year after last dose

• Changes in HBsAg levels

  Up to 1 year after last dose

Study Arms (1)

LioCyx-M (Autologous T-cells transfected with mRNA encoding HBV antigen specific TCR)

EXPERIMENTAL

Escalating doses of LioCyx-M from 5×10E05 to 50×10E06 cells/kg body weight (BW), administered every two weeks.

Biological: LioCyx-M

Interventions

LioCyx-M BIOLOGICAL

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

LioCyx-M (Autologous T-cells transfected with mRNA encoding HBV antigen specific TCR)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Changhai Hospital: lead
• Guangzhou Lion TCR Co Ltd: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

CN (1)