This is a single-arm and open-label study to assess the safety, tolerability and primary efficacy of the HBV specific T cell receptor (HBV/TCR) redirected T cell in patients with recurrent Hepatitis B virus (HBV) related hepatocellular carcinoma post liver transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Patients will receive 1 x 10\^4 cells/kg to 5 x 10\^6 cells/kg bodyweight of TCR redirected T cells by IV infusion.
The First Affiliated Hospital of Sun-Yat Sen University
Guangzhou, Guangdong, China
Safety evaluation of the TCR-T treatment
Incidence of adverse events/serious adverse events
Time frame: Start of Treatment until 28 days post last dose
Overall Response Rate
Tumour assessment will be according to RECIST v1.1. This is based on percentage of participants with Complete Response (CR) and Partial Response (PR) according to RECIST v1.1 from baseline.
Time frame: Start of treatment until disease progression, and subsequent follow up up to 24 months post treatment.
Progression-free survival (PFS)
1-year PFS is measured by the number of patients with stable disease after 1 year, using RECIST v1.1.
Time frame: Start of treatment until disease progression, and at 6-month and 1-year.
Overall survival (OS)
OS is defined as the time from randomisation until death by any cause. Participants will be followed up for survival follow up for two years.
Time frame: Start of treatment until disease progression, and at 6-month and 1-year.
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