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Clinical Trials in China / NCT06885710
Recruiting Phase 1

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

NCT06885710 · tracked via the Priya Life Science China tracker
Sponsor
Changhai Hospital
Phase
Phase 1
Started
2024-12-31
Last updated
2025-07-17

Condition(s) studied

Chronic Hepatitis b

Investigational drug(s) / intervention(s)

LioCyx-M

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Changhai Hospital Shanghai China Recruiting

More Changhai Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06885710 on ClinicalTrials.gov ↗ ← All trials in China