HBV-specific T-cell therapy for chronic hepatitis B patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Changhai Hospital
  Shanghai, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Impact of functional cure on patient-reported outcomes in chronic hepatitis B

  This study tests whether people with chronic hepatitis B who achieve a functional cure have better patient-reported outcomes compared to those not cured, relapse, or healthy controls.

  Recruiting Third Affiliated Hospital, Sun Yat-Sen University · Guangzhou · NCT07855029

• Sequential combination therapy for functional cure of chronic hepatitis B

  This trial tests a new two-drug approach to see if adding immunotherapy to ongoing HBV treatment can lead to loss of hepatitis B surface antigen in adults with chronic hepatitis B.

  Recruiting Phase 2 The Second Affiliated Hospital of Chongqing Medical University · Chongqing, Chongqing Municipality · NCT07852091

• Combination therapy for functional cure in chronic hepatitis B

  This phase 2 trial tests whether a sequence of anti-PD-1/PD-L1 antibodies with pegylated interferon and nucleos(t)ide analogues can achieve functional cure (HBsAg loss) in adults with chronic hepatitis B.

  Recruiting Phase 2 The Second Affiliated Hospital of Chongqing Medical University · Chongqing, Chongqing Municipality · NCT07845058

• GST-HG131/GST-HG141 tablets vs placebo in chronic hepatitis B

  A phase IIa trial tests GST-HG131 and GST-HG141 tablets against placebo to see if they are safe and help people with chronic hepatitis B.

  Recruiting Phase 2 Fujian Akeylink Biotechnology Co., Ltd. · Beijing · NCT07709520

• AHB-137 injection in people with chronic hepatitis B

  This study tests AHB-137 vs placebo in adults with chronic hepatitis B who have not yet received antiviral treatment.

  Recruiting at 34 sites Phase 2 Ausper Biopharma Co., Ltd. · Beijing, Beijing Municipality and 33 other locations · NCT07635186

• AHB-137 injection pharmacokinetics and safety in people with mild to moderate liver dysfunction and normal liver function

  This study tests how AHB-137 behaves in the body and its safety in adults with chronic hepatitis B who have mild to moderate liver problems or normal liver function.

  Recruiting Phase 1 Ausper Biopharma Co., Ltd. · Chongqing, Chongqing Municipality and 4 other locations · NCT07600788

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.