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.
A open-label, cohort clinical study of T cell receptor-redirected T cells to prevent recurrence of HBV-related hepatocellular carcinoma after liver transplantation. Subjects will be enrolled into the observation cohort or treatment cohort. Subjects enrolled in the treatment group will receive escalating doses of HBV/ TCR expressing autologous T cells after confirming eligibility. The interval between the first two doses is 14 days, followed by one month of safety monitoring, before subsequent two doses of 1 month interval in between. Thereafter, subjects would enter into observation period of the safety and tolerability of the treatment and will be followed up until disease relapse. Upon disease recurrence, eligible patient may receive HBV specific T-cell receptor (TCR-T) treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
13
Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
The First Affiliated Hospital, Sun-Yat Sen University
Guangzhou, Guangdong, China
To Evaluate safety of the TCR-T treatment
Measures include \- assessments of Adverse Events (AEs) and Serious AEs,
Time frame: Start of Treatment until 28 days post last dose
To evaluate Progression Free Survival rate
PFS
Time frame: Start of Treatment until disease progression, and subsequent follow up for 2 years or death (whichever comes first)
To evaluate Duration of response rate
DOR
Time frame: Start of Treatment until disease progression, and subsequent follow up for 2 years or death (whichever comes first)
To evaluate objective response rate
ORR
Time frame: Start of Treatment until disease progression, and subsequent follow up for 2 years or death (whichever comes first)
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