Status:
UNKNOWN
TCR-Redirected T Cell Treatment in Patients With Recurrent HBV-related Hepatocellular Carcinoma Post Liver Transplantation
Lead Sponsor:
Xiaoshun He
Collaborating Sponsors:
Lion TCR Pte. Ltd.
Conditions:
Recurrent Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- Diagnosis as hepatocellular carcinoma (HCC).
- Recurrent locally advanced and/or metastatic hepatocellular carcinoma (HCC) post liver transplantation.
- Seropositive for hepatitis B surface antigen, or presence of HBV DNA or HBV RNA.
- HLA profile matching with HLA-class I restriction element of the available T cell receptors.
- ECOG performance status ≤ 2.
- Laboratory criteria:
- Liver function: ALT and AST ≤ 5 of upper limit of normal (ULN), TBIL ≤ 3 x ULN.
- Neutrophil cell number ≥1.5×10\^9/L.
- Platelet count ≥100×10\^9/L.
- Ability to provide informed consent.
- Willing and able to comply with all study procedures.
Exclusion
- Second primary malignancy that is clinically detectable at the time of consideration for study enrolment.
- Likelihood to require steroid treatment during the period of the clinical trial.
- Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- 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.
- Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study.
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04677088
Start Date
March 29 2018
End Date
December 1 2021
Last Update
December 21 2020
Active Locations (1)
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1
The First Affiliated Hospital of Sun-Yat Sen University
Guangzhou, Guangdong, China, 510080