This is a single center, single arm and open-label study to determine the safety of mRNA modified HBV-TCR redirected T-cells and to analyze the changes in tumor microenvironment caused by these HBV-TCR redirected T-cells in subjects with HBV-related HCC who are not amenable to/failed conventional treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Study Infusion The first dose of mRNA HBV-TCR T-cells at dose 1x10e5/kg BW will be infused on Day 0, and subsequently incremental doses on Day 14 and 28, up to the dose of 5-10x10e6/kg BW.
Singapore General Hospital
Singapore, Singapore
RECRUITINGSafety evaluation of mRNA HBV/TCR T-cell treatment
Based on incidence and severity of adverse events
Time frame: Start of treatment until 28 days post last dose
Analysis of modifications of tumour microenvironment caused by mRNA HBV/TCR T-cell treatment
Histological staining using biopsy and analysis of serum factors such as cytokines and chemokines
Time frame: Start of treatment until end of study
Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment
Objective response rate (ORR)
Time frame: Up to 4 years
Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment
Progression free survival (PFS)
Time frame: Up to 4 years
Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment
Overall survival (OS)
Time frame: Up to 4 years
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