A Study of TCR-Redirected T Cell Infusion to Prevent Hepatocellular Carcinoma Recurrence Post Liver Transplantation
NCT ID: NCT02686372
Last Updated: 2022-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2018-05-16
2021-09-28
Brief Summary
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Detailed Description
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Subjects enrolled in the treatment group will receive escalating doses of HBV/ TCR expressing autologous T cells after confirming eligibility. The interval between the first two doses is 14 days, followed by one month of safety monitoring, before subsequent two doses of 1 month interval in between. Thereafter, subjects would enter into observation period of the safety and tolerability of the treatment and will be followed up until disease relapse.
Upon disease recurrence, eligible patient may receive HBV specific T-cell receptor (TCR-T) treatment.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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HBV/TCR-T cell infusion
Subjects enrolled in the experimental (treatment) group will receive escalating doses of HBV/ TCR expressing autologous T cells. The interval between the first two doses is 14 days, followed by one month of safety monitoring, before subsequent two doses of 1 month interval in between. Thereafter, subjects would enter into observation period of the safety and tolerability of the treatment and will be followed up until disease relapse.
TCR-T
Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
No intervention and TCR-T (at crossover)
No intervention and to be crossover to experimental arm upon confirmation of disease recurrence.
No intervention and TCR-T (at crossover)
Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
Interventions
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TCR-T
Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
No intervention and TCR-T (at crossover)
Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
Eligibility Criteria
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Inclusion Criteria
* Underwent liver transplantation
* Seropositive for hepatitis B surface antigen (HBsAg), or presence of HBV DNA or HBV RNA before liver transplantation
* Expression of TCR-T target epitopes within specific human leukocyte antigen (HLA) class I profile
* No major post-operative complication
* Life expectancy of at least 3 months
* Ability to provide informed consent
* Ability to comply with study procedures
Exclusion Criteria
* Significant ongoing immunologic rejection based on pathology and clinical diagnosis
* Evidence or history of significant bleeding diathesis or coagulopathy
* Prior exposure to any cell therapy such as, but not limited to NK, CIK, DC, CTL, stem cells therapy
* Known history of testing positive for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* Women who are pregnant or breast-feeding
* Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study
18 Years
75 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Lion TCR Pte. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaoshun He, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Locations
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The First Affiliated Hospital, Sun-Yat Sen University
Guangzhou, Guangdong, China
Countries
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References
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Qasim W, Brunetto M, Gehring AJ, Xue SA, Schurich A, Khakpoor A, Zhan H, Ciccorossi P, Gilmour K, Cavallone D, Moriconi F, Farzhenah F, Mazzoni A, Chan L, Morris E, Thrasher A, Maini MK, Bonino F, Stauss H, Bertoletti A. Immunotherapy of HCC metastases with autologous T cell receptor redirected T cells, targeting HBsAg in a liver transplant patient. J Hepatol. 2015 Feb;62(2):486-91. doi: 10.1016/j.jhep.2014.10.001. Epub 2014 Oct 13.
Gehring AJ, Xue SA, Ho ZZ, Teoh D, Ruedl C, Chia A, Koh S, Lim SG, Maini MK, Stauss H, Bertoletti A. Engineering virus-specific T cells that target HBV infected hepatocytes and hepatocellular carcinoma cell lines. J Hepatol. 2011 Jul;55(1):103-10. doi: 10.1016/j.jhep.2010.10.025. Epub 2010 Nov 23.
Koh S, Shimasaki N, Suwanarusk R, Ho ZZ, Chia A, Banu N, Howland SW, Ong AS, Gehring AJ, Stauss H, Renia L, Sallberg M, Campana D, Bertoletti A. A practical approach to immunotherapy of hepatocellular carcinoma using T cells redirected against hepatitis B virus. Mol Ther Nucleic Acids. 2013 Aug 13;2(8):e114. doi: 10.1038/mtna.2013.43.
Other Identifiers
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LTCR-HCC-1-1
Identifier Type: -
Identifier Source: org_study_id
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