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

Phase 1

• Conditions: Recurrent Hepatocellular Carcinoma
• Interventions: Biological: TCR-T cells

• Registration Number: NCT04677088
• Lead Sponsor: Xiaoshun He

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-29
• Primary Completion: 2020-02-18
• Status Verified: 2020-12
• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-16
• Last Update Submitted: 2020-12-16
• Study First Posted: 2020-12-21
• Last Update Posted: 2020-12-21
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HBV/ TCR T cell infusion	TCR-T cells	Autologous T cells with HBV antigen-specific TCR

Primary Outcome Measures

Name	Time	Method
Safety evaluation of the TCR-T treatment	Start of Treatment until 28 days post last dose	Incidence of adverse events/serious adverse events

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	Start of treatment until disease progression, and subsequent follow up up to 24 months post treatment.	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.
Progression-free survival (PFS)	Start of treatment until disease progression, and at 6-month and 1-year.	1-year PFS is measured by the number of patients with stable disease after 1 year, using RECIST v1.1.
Overall survival (OS)	Start of treatment until disease progression, and at 6-month and 1-year.	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun-Yat Sen University; 🇨🇳 Guangzhou, Guangdong, China