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

Xiaoshun He1 site in 1 country7 target enrollmentMarch 29, 2018

ConditionsRecurrent Hepatocellular Carcinoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Recurrent Hepatocellular Carcinoma
Sponsor: Xiaoshun He
Enrollment: 7
Locations: 1
Primary Endpoint: Safety evaluation of the TCR-T treatment
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 virus (HBV) related hepatocellular carcinoma post liver transplantation.

Registry

clinicaltrials.gov

Start Date

March 29, 2018

End Date

December 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Xiaoshun He

Responsible Party

Sponsor Investigator

Principal Investigator

Xiaoshun He

MD.

First Affiliated Hospital, Sun Yat-Sen University

Eligibility Criteria

Inclusion Criteria

•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 ≤
•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Safety evaluation of the TCR-T treatment

Time Frame: Start of Treatment until 28 days post last dose

Incidence of adverse events/serious adverse events

Secondary Outcomes

Overall Response Rate(Start of treatment until disease progression, and subsequent follow up up to 24 months post treatment.)
Progression-free survival (PFS)(Start of treatment until disease progression, and at 6-month and 1-year.)
Overall survival (OS)(Start of treatment until disease progression, and at 6-month and 1-year.)