HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients
NCT06885710 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2025-07-17
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
- BIOLOGICAL
-
LioCyx-M
Each patient will receive LioCyx-M infusion every one or two weeks, while continuing their existing nucleos(t)ide analog treatment.
Sponsors & Collaborators
-
Guangzhou Lion TCR Co Ltd
collaborator UNKNOWN -
Changhai Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-31
- Primary Completion
- 2027-12-01
- Completion
- 2028-12-01
Countries
- China
Study Locations
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