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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.

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.

Condition or disease Intervention/treatment Phase
Recurrent Hepatocellular Carcinoma Other: Biological: HBV antigen specific TCR redirected T cell Phase 1 Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study T Cell Receptor-Redirected T Cells Infusions to Treat Patients With Recurrent HBV-Related Hepatocellular Carcinoma Post Liver Transplantation
Study Start Date : December 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: HBV/TCR T cell Infusion
Biological: HBV antigen specific TCR redirected T cell
Other: Biological: HBV antigen specific TCR redirected T cell
Patients will receive escalating doses of HBV specific TCR redirected T cell infusion



Primary Outcome Measures :
  1. Safety of the TCR treatment (according to CTCAE 4.0) [ Time Frame: Baseline until 1 month after last treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. Systemic release of inflammatory cytokines after administration of transduced T cells compared to baseline [ Time Frame: Baseline until release from hospital, about 2 weeks ]

Other Outcome Measures:
  1. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719782


Contacts
Contact: Lietao Li, MD (65) 6224 6157 clinicaltrials@liontcr.com

Locations
China, Guangdong
Third Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Qi Zhang, Ph.D, MD    (86)20-85253106      
Sponsors and Collaborators
Lion TCR Pte. Ltd.
Agency for Science, Technology and Research
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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

Publications:
Responsible Party: Lion TCR Pte. Ltd.
ClinicalTrials.gov Identifier: NCT02719782     History of Changes
Other Study ID Numbers: LTCR-HCC-I-2
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases