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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02686372 on ClinicalTrials.gov