Trials / Recruiting
RecruitingNCT06885710
HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in 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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (estimated)
- Sponsor
- Changhai Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | LioCyx-M | Each patient will receive LioCyx-M infusion every one or two weeks, while continuing their existing nucleos(t)ide analog treatment. |
Timeline
- Start date
- 2024-12-31
- Primary completion
- 2027-12-01
- Completion
- 2028-12-01
- First posted
- 2025-03-20
- Last updated
- 2025-07-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06885710. Inclusion in this directory is not an endorsement.