ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of TCR-Redirected T Cell Infusion in Subject With Recurrent HBV-related HCC Post Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02719782
Recruitment Status : Recruiting
First Posted : March 25, 2016
Last Update Posted : September 18, 2018
Sponsor:
Collaborators:
Agency for Science, Technology and Research
Third Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Lion TCR Pte. Ltd.

March 21, 2016
March 25, 2016
September 18, 2018
July 2, 2015
May 2019   (Final data collection date for primary outcome measure)
Safety of the TCR-T treatment [ Time Frame: Start of treament until 1 month after last treatment ]
Safety of the TCR treatment (according to CTCAE 4.0) [ Time Frame: Baseline until 1 month after last treatment ]
Complete list of historical versions of study NCT02719782 on ClinicalTrials.gov Archive Site
  • Efficacy of induction of tumor specific T cell responses as measured by the persistence of HBV specific T cells in peripheral blood samples at several time points following adoptive transfer [ Time Frame: Start of treatment until disease progression, and subsequent follow up up to 24 months post treatment ]
  • Systemic release of inflammatory cytokines after administration of transduced T cells compared to baseline [ Time Frame: Start of treatment until disease progression, and subsequent follow up up to 24 months post treatment ]
  • Efficacy of induction of tumor specific T cell responses as measured by the persistence of HBV specific T cells in peripheral blood samples at several time points following adoptive transfer [ Time Frame: Baseline until release from hospital, about 2 weeks ]
  • Systemic release of inflammatory cytokines after administration of transduced T cells compared to baseline [ Time Frame: Baseline until release from hospital, about 2 weeks ]
1-year PFS (progression free survival) which is measured by the number of patients with stable disease after 1 year, using mRECIST [ Time Frame: Start of treatment until disease progression, median 6 months ]
1-year PFS (progression free survival) will we measured by the number of patients with stable disease after 1 year, using RECIST 1.1 to measure progressive disease [ Time Frame: Baseline until progressive disease, median 6 months ]
 
A Study of TCR-Redirected T Cell Infusion in Subject With Recurrent HBV-related HCC Post Liver Transplantation
A Phase I Study T Cell Receptor-Redirected T Cells Infusions in Subjects With Recurrent HBV-Related Hepatocellular Carcinoma in Post Liver Transplantation
Hepatocellular carcinoma (HCC) recurrence rate is high among liver transplant patients, while treatment measures are limited. This study plans to recruit 10 patients with Hepatitis B virus (HBV) related HCC who underwent liver transplantation and are confirmed to have recurrent HCC. 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.
This is a phase I, single armed and open labelled trial in patients with recurrent HBV related HCC after liver transplantation. Subjects who meet eligibility criteria will receive escalating doses of HBV specific T cell receptor (TCR-T) on Day 1, Day 8, Day 15 and Day 22 of the first 28-day treatment cycle, followed by every 2-week dosing on Day 1, Day 15, Day 29 and Day 43 of repeated cycle. A 21-day treatment break will be given between each cycle. Treatment will be continued until disease progression unless otherwise specified per investigator's discretion. Subjects will be followed up post treatment for safety monitoring, including monthly follow up for the first three month and every 2-monthly follow up up to 24 months post treatment.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Recurrent Hepatocellular Carcinoma
Biological: Biological: HBV antigen specific TCR redirected T cell (TCR-T)
Patients will receive escalating doses of TCR-T on Day 1, Day 8, Day 15 and Day 22 of the first 28-day treatment cycle, followed by every 2-week dosing on Day 1, Day 15, Day 29 and Day 43 of repeated cycles until disease progression unless otherwise specified per investigator's discretion. A 21-day treatment break will be given between each cycle.
Experimental: HBV/TCR T cell Infusion
Biological: HBV antigen specific TCR redirected T cell
Intervention: Biological: Biological: HBV antigen specific TCR redirected T cell (TCR-T)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Same as current
December 2019
May 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis as hepatocellular carcinoma (HCC)
  • Underwent liver transplantation and confirmed recurrent HCC post operation
  • Seropositive for hepatitis B surface antigen
  • No major post-operative complication
  • Life expectancy of at least 12 weeks
  • Ability to provide informed consent
  • Ability to comply with study procedures
  • HLA profile matching with HLA-class I restriction element of the available T cell receptors

Exclusion Criteria:

  • Administration of any other cell therapy, including NK, CIK, DC, CTL, CAR-T, stem cells or combined therapy of the kind within 3 months prior to enrolment
  • 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
  • Any other concurrent liver infections such as hepatitis A, C or D infection
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
  • Known Central Nervous System tumours including metastatic brain disease.
  • Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study
  • Patients with reproductive potential who tested positive for serum or urine pregnancy test result within 14 days prior to enrolment.
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult, Older Adult)
No
Contact: Grace Khoo Koay (65) 69260818 clinicaltrials@liontcr.com
Contact: Xiaofang Zheng 86-(020)-8217-9791
China
 
 
NCT02719782
LTCR-HCC-2-1
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Lion TCR Pte. Ltd.
Lion TCR Pte. Ltd.
  • Agency for Science, Technology and Research
  • Third Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Qi Zhang, MD Third Affiliated Hospital, Sun Yat-Sen University
Study Chair: Antonio Bertoletti, MD Duke-NUS Graduate Medical School
Lion TCR Pte. Ltd.
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP