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TCR-Redirected T Cell Infusions to Treat Recurrent Hepatocellular Carcinoma Post Liver Transplantation

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ClinicalTrials.gov Identifier: NCT02719782
Recruitment Status : Recruiting
First Posted : March 25, 2016
Last Update Posted : March 25, 2016
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
March 25, 2016
December 2015
November 2017   (Final data collection date for primary outcome measure)
Safety of the TCR treatment (according to CTCAE 4.0) [ Time Frame: Baseline until 1 month after last treatment ]
Same as current
No Changes Posted
  • 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 ]
Same as current
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 ]
Same as current
 
TCR-Redirected T Cell Infusions to Treat Recurrent Hepatocellular Carcinoma Post Liver Transplantation
Phase I Study T Cell Receptor-Redirected T Cells Infusions to Treat Patients With Recurrent HBV-Related Hepatocellular Carcinoma 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 single armed and open labelled trial in patients with recurrent HBV related HCC after liver transplantation. For patients who successfully match TCR histocompatibility locus antigen (HLA) restriction, escalating doses of HBV/TCR expressing autologous T cells will be infused. Tests will be done to confirmed safety and efficacy during treatment, followed by one month immediate observation period for safety and a long-term follow up period up to five years for efficacy.
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Recurrent Hepatocellular Carcinoma
Other: Biological: HBV antigen specific TCR redirected T cell
Patients will receive escalating doses of HBV specific TCR redirected T cell infusion
Experimental: HBV/TCR T cell Infusion
Biological: HBV antigen specific TCR redirected T cell
Intervention: Other: Biological: HBV antigen specific TCR redirected T cell

*   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
November 2020
November 2017   (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
18 Years to 65 Years   (Adult, Older Adult)
No
Contact: Lietao Li, MD (65) 6224 6157 clinicaltrials@liontcr.com
China
 
 
NCT02719782
LTCR-HCC-I-2
No
Not Provided
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: Guihua Chen, MD 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.
March 2016

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