Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

TCR-Redirected T Cell Infusions to Prevent Hepatocellular Carcinoma Recurrence 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: 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.

Tracking Information
First Submitted Date  ICMJE February 17, 2016
First Posted Date  ICMJE February 19, 2016
Last Update Posted Date March 22, 2016
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2016)
Safety of the TCR treatment (according to CTCAE 4.0) [ Time Frame: Baseline until one month after last treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
Number of patient with > grade 3 adverse event base on Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0 [ Time Frame: 2 Years ]
Change History Complete list of historical versions of study NCT02686372 on ClinicalTrials.gov Archive Site
Current 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
Presence of T cell expressing antigen-specific TCR in vivo [ Time Frame: 2 months ]
Current Other Pre-specified Outcome Measures
 (submitted: March 21, 2016)
Systemic release of inflammatory cytokines after administration of transduced T cells compared to baseline [ Time Frame: Baseline until release from hospital, about 2 weeks ]
Original Other Pre-specified Outcome Measures
 (submitted: February 17, 2016)
Serum cytokine level in vivo [ Time Frame: 2 months ]
 
Descriptive Information
Brief Title  ICMJE TCR-Redirected T Cell Infusions to Prevent Hepatocellular Carcinoma Recurrence Post Liver Transplantation
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE Other: Biological: HBV antigen specific TCR redirected T cell
Subjects will receive escalating doses of HBV antigen specific TCR redirected T cell infusion.
Study Arms  ICMJE Experimental: HBV/TCR-T cell
Biological: HBV antigen specific TCR redirected T cell infusion.
Intervention: Other: Biological: HBV antigen specific TCR redirected T cell
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: February 17, 2016)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lietao Li, MD (65) 6224 6157 clinicaltrials@liontcr.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02686372
Other Study ID Numbers  ICMJE LTCR-HCC-I-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lion TCR Pte. Ltd.
Study Sponsor  ICMJE Lion TCR Pte. Ltd.
Collaborators  ICMJE
  • First Affiliated Hospital, Sun Yat-Sen University
  • Agency for Science, Technology and Research
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators  ICMJE
Principal Investigator: Xiaoshun He, MD First Affiliated Hospital, Sun Yat-Sen University
Study Chair: Antonio Bertoletti, MD Duke-NUS Graduate Medical School
PRS Account Lion TCR Pte. Ltd.
Verification Date March 2016

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