TCR-Redirected T Cell Treatment in Patients With Recurrent HBV-related Hepatocellular Carcinoma Post Liver Transplantation

Phase I Study of T Cell Receptor-Redirected T Cells With Recurrent HBV Treatment in Patients-Related Hepatocellular Carcinoma in Post Liver Transplantation

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.

Inclusion Criteria:

1. Diagnosis as hepatocellular carcinoma (HCC).

2. Recurrent locally advanced and/or metastatic hepatocellular carcinoma (HCC) post liver transplantation.

3. Seropositive for hepatitis B surface antigen, or presence of HBV DNA or HBV RNA.

4. HLA profile matching with HLA-class I restriction element of the available T cell receptors.

5. ECOG performance status ≤ 2.

6. Laboratory criteria:

   1. Liver function: ALT and AST ≤ 5 of upper limit of normal (ULN), TBIL ≤ 3 x ULN.
   2. Neutrophil cell number ≥1.5×10^9/L.
   3. Platelet count ≥100×10^9/L.

7. Ability to provide informed consent.

8. Willing and able to comply with all study procedures.

Exclusion Criteria:

1. Second primary malignancy that is clinically detectable at the time of consideration for study enrolment.
2. Likelihood to require steroid treatment during the period of the clinical trial.
3. Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples.
4. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
5. Administration of any other cell therapy, including NK, CIK, DC, CTL, CAR- T, stem cells or combined therapy of the kind within 28 days prior to start of treatment.
6. Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study.