A Study of TCR-Redirected T Cell Infusion to Prevent Hepatocellular Carcinoma Recurrence Post Liver Transplantation
NCT02686372 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2022-06-30
Summary
Hepatocellular Carcinoma (HCC) recurrence rate is high among liver transplant patients, while treatment measures are limited. This study plans to recruit 39 subjects with Hepatitis B virus (HBV) related HCC after liver transplantation. The objective of the study is to assess the safety, tolerability and effectiveness of the HBV specific T cell receptor (HBV/TCR) redirected T cell in the target population.
Conditions
Interventions
- BIOLOGICAL
-
TCR-T
Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
- BIOLOGICAL
-
No intervention and TCR-T (at crossover)
Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
Sponsors & Collaborators
-
First Affiliated Hospital, Sun Yat-Sen University
collaborator OTHER -
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
collaborator OTHER -
Lion TCR Pte. Ltd.
lead INDUSTRY
Principal Investigators
-
Xiaoshun He, MD · First Affiliated Hospital, Sun Yat-Sen University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-16
- Primary Completion
- 2021-09-28
- Completion
- 2021-09-28
Countries
- China
Study Locations
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