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Trial record 227 of 324 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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.

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.

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

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
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
Biological: HBV antigen specific TCR redirected T cell infusion.
Other: Biological: HBV antigen specific TCR redirected T cell
Subjects will receive escalating doses of HBV antigen specific TCR redirected T cell infusion.



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

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


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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
  • 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

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): NCT02686372


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

Locations
China, Guangdong
The First Affiliated Hospital, Sun-Yat Sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Xiaoshun He, MD    (86) 020-8730-6082    gdtrc@126.com   
Contact: Qiang Zhao, Ph.D    (86) 159-8919-6835    522511042@qq.com   
Principal Investigator: Xiaoshun He, MD         
Sponsors and Collaborators
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
Investigators
Principal Investigator: Xiaoshun He, MD First 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: NCT02686372     History of Changes
Other Study ID Numbers: LTCR-HCC-I-1
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lion TCR Pte. Ltd.:
hepatocellular carcinoma

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