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

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ClinicalTrials.gov Identifier: NCT02719782
Recruitment Status : Recruiting
First Posted : March 25, 2016
Last Update Posted : November 16, 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.

Tracking Information
First Submitted Date  ICMJE March 21, 2016
First Posted Date  ICMJE March 25, 2016
Last Update Posted Date November 16, 2018
Actual Study Start Date  ICMJE July 2, 2015
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2018)
Safety of the TCR-T treatment [ Time Frame: Start of treament until 1 month after last treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2016)
Safety of the TCR treatment (according to CTCAE 4.0) [ Time Frame: Baseline until 1 month after last treatment ]
Change History Complete list of historical versions of study NCT02719782 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures
 (submitted: September 16, 2018)
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 ]
Original Other Pre-specified Outcome Measures
 (submitted: March 21, 2016)
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 ]
 
Descriptive Information
Brief Title  ICMJE A Study of TCR-Redirected T Cell Infusion in Subject With Recurrent HBV-related HCC Post Liver Transplantation
Official Title  ICMJE A Phase I Study T Cell Receptor-Redirected T Cells Infusions in Subjects With Recurrent HBV-Related Hepatocellular Carcinoma in Post Liver Transplantation
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Hepatocellular Carcinoma
Intervention  ICMJE Biological: Biological: TCR-T
Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
Study Arms  ICMJE Experimental: HBV/TCR T cell Infusion

This is a single-arm study.

Patients will receive a total of 2 cycles, in which first 28-day treatment cycle consists of escalating doses of TCR-T on Day 1, Day 8, Day 15 and Day 22, followed by every 2-week dosing on Day 1, Day 15, Day 29 and Day 43 of second (final) cycle. A one month treatment break will be given between the cycles.

Intervention: Biological: Biological: TCR-T
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2016)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Grace Khoo Koay (65) 69260818 clinicaltrials@liontcr.com
Contact: Xiaofang Zheng 86-(020)-8217-9791
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02719782
Other Study ID Numbers  ICMJE LTCR-HCC-2-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lion TCR Pte. Ltd.
Study Sponsor  ICMJE Lion TCR Pte. Ltd.
Collaborators  ICMJE
  • Agency for Science, Technology and Research
  • Third Affiliated Hospital, Sun Yat-Sen University
Investigators  ICMJE
Principal Investigator: Qi Zhang, MD Third Affiliated Hospital, Sun Yat-Sen University
Study Chair: Antonio Bertoletti, MD Duke-NUS Graduate Medical School
PRS Account Lion TCR Pte. Ltd.
Verification Date November 2018

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