HBV-specific T-cell therapy for 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
This study is testing a new treatment using modified T-cells to see if it can help people with chronic hepatitis B feel better and fight the virus more effectively.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 19 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06885710 on ClinicalTrials.gov |
What this trial studies
This open-label study evaluates the safety and efficacy of autologous T-cells that have been modified with mRNA to express Hepatitis B virus-specific T cell receptors, combined with nucleos(t)ide analogues in patients with chronic hepatitis B who are HBeAg-positive. The trial aims to determine how well this innovative therapy works in targeting the virus and improving patient outcomes. Participants will undergo treatment with LioCyx-M, and their progress will be monitored throughout the study.
Who should consider this trial
Good fit: Ideal candidates are HBeAg-positive chronic hepatitis B patients with specific HLA class 1 profiles and liver disease consistent with chronic HBV infection.
Not a fit: Patients with chronic liver diseases unrelated to HBV, decompensated liver function, or those with a positive HIV test may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel and effective treatment option for patients suffering from chronic hepatitis B.
How similar studies have performed: While this approach is innovative, similar studies using T-cell therapies for viral infections have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Shanghai
- Changhai Hospital — Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.