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| Name | Class |
|---|---|
| Lion TCR Pte. Ltd. | INDUSTRY |
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This is a single-arm and open-label study to assess the safety, tolerability and primary efficacy of the HBV specific T cell receptor (HBV/TCR) redirected T cell in patients with recurrent Hepatitis B virus (HBV) related hepatocellular carcinoma post liver transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBV/ TCR T cell infusion | Experimental | Autologous T cells with HBV antigen-specific TCR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCR-T cells | Biological | Patients will receive 1 x 10^4 cells/kg to 5 x 10^6 cells/kg bodyweight of TCR redirected T cells by IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation of the TCR-T treatment | Incidence of adverse events/serious adverse events | Start of Treatment until 28 days post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Tumour assessment will be according to RECIST v1.1. This is based on percentage of participants with Complete Response (CR) and Partial Response (PR) according to RECIST v1.1 from baseline. | Start of treatment until disease progression, and subsequent follow up up to 24 months post treatment. |
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Inclusion Criteria:
Diagnosis as hepatocellular carcinoma (HCC).
Recurrent locally advanced and/or metastatic hepatocellular carcinoma (HCC) post liver transplantation.
Seropositive for hepatitis B surface antigen, or presence of HBV DNA or HBV RNA.
HLA profile matching with HLA-class I restriction element of the available T cell receptors.
ECOG performance status ≤ 2.
Laboratory criteria:
Ability to provide informed consent.
Willing and able to comply with all study procedures.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun-Yat Sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30711630 | Background | Tan AT, Yang N, Lee Krishnamoorthy T, Oei V, Chua A, Zhao X, Tan HS, Chia A, Le Bert N, Low D, Tan HK, Kumar R, Irani FG, Ho ZZ, Zhang Q, Guccione E, Wai LE, Koh S, Hwang W, Chow WC, Bertoletti A. Use of Expression Profiles of HBV-DNA Integrated Into Genomes of Hepatocellular Carcinoma Cells to Select T Cells for Immunotherapy. Gastroenterology. 2019 May;156(6):1862-1876.e9. doi: 10.1053/j.gastro.2019.01.251. Epub 2019 Jan 31. | |
| 25308176 |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Progression-free survival (PFS) |
1-year PFS is measured by the number of patients with stable disease after 1 year, using RECIST v1.1. |
| Start of treatment until disease progression, and at 6-month and 1-year. |
| Overall survival (OS) | OS is defined as the time from randomisation until death by any cause. Participants will be followed up for survival follow up for two years. | Start of treatment until disease progression, and at 6-month and 1-year. |
| Background |
| 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. |
| 21145860 | Background | 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. |
| 23941866 | Background | 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. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |