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TCR-Redirected T Cell Infusions to Prevent Hepatocellular Carcinoma Recurrence Post Liver Transplantation

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ClinicalTrials.gov Identifier: NCT02686372
Recruitment Status : Recruiting
First Posted : February 19, 2016
Last Update Posted : March 22, 2016
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Agency for Science, Technology and Research
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Information provided by (Responsible Party):
Lion TCR Pte. Ltd.

February 17, 2016
February 19, 2016
March 22, 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 one month after last treatment ]
Number of patient with > grade 3 adverse event base on Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0 [ Time Frame: 2 Years ]
Complete list of historical versions of study NCT02686372 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: Baseline until release from hospital, about 2 weeks ]
Presence of T cell expressing antigen-specific TCR in vivo [ Time Frame: 2 months ]
Systemic release of inflammatory cytokines after administration of transduced T cells compared to baseline [ Time Frame: Baseline until release from hospital, about 2 weeks ]
Serum cytokine level in vivo [ Time Frame: 2 months ]
 
TCR-Redirected T Cell Infusions to Prevent Hepatocellular Carcinoma Recurrence Post Liver Transplantation
Phase I Study of T Cell Receptor-Redirected T Cells Infusions for Preventing Hepatocellular Carcinoma Recurrence in Patients With HBV-Related Disease 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 subjects with Hepatitis B virus (HBV) related HCC after liver transplantation. 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.
A single armed and open labelled trial in patients with hepatocellular carcinoma and HBV infection (HBsAg+) post 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 the two-month treatment and observation period and twice each year of a follow up period up to five years.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Hepatocellular Carcinoma
Other: Biological: HBV antigen specific TCR redirected T cell
Subjects will receive escalating doses of HBV antigen specific TCR redirected T cell infusion.
Experimental: HBV/TCR-T cell
Biological: HBV antigen specific TCR redirected T cell infusion.
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
  • Seropositive for hepatitis B surface antigen before liver transplantation
  • No major post-operative complication
  • Life expectancy of at least 12 weeks
  • Ability to provide informed consent
  • Ability to comply with study procedures
  • Patients with reproductive potential must agree to use an approved contraceptive method, and are tested negative for serum or urine pregnancy test result within 14 days prior to enrolment.

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
  • HLA profile not matching with HLA-class I restriction element of the available T cell receptors
  • 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
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
 
 
NCT02686372
LTCR-HCC-I-1
No
Not Provided
Plan to Share IPD: No
Lion TCR Pte. Ltd.
Lion TCR Pte. Ltd.
  • First Affiliated Hospital, Sun Yat-Sen University
  • Agency for Science, Technology and Research
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Principal Investigator: Xiaoshun He, MD First 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