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Status unknownNCT04677088Updated Dec 21, 2020

TCR-Redirected T Cell Treatment in Patients With Recurrent HBV-related Hepatocellular Carcinoma Post Liver Transplantation

A Phase 1 interventional study of TCR-T cells in Recurrent Hepatocellular Carcinoma, sponsored by Xiaoshun He. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-21.

Sponsored by Xiaoshun He · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Mar 2018, registered Dec 2020).
Phase
Phase 1
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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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Conditions studied

  • Recurrent Hepatocellular Carcinoma
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 7 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

This is the only study on the registry with Xiaoshun He as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosis as hepatocellular carcinoma (HCC).
  2. Recurrent locally advanced and/or metastatic hepatocellular carcinoma (HCC) post liver transplantation.
  3. Seropositive for hepatitis B surface antigen, or presence of HBV DNA or HBV RNA.
  4. HLA profile matching with HLA-class I restriction element of the available T cell receptors.
  5. ECOG performance status ≤ 2.

  6. Laboratory criteria:

    1. Liver function: ALT and AST ≤ 5 of upper limit of normal (ULN), TBIL ≤ 3 x ULN.
    2. Neutrophil cell number ≥1.5×10\^9/L.
    3. Platelet count ≥100×10\^9/L.
  7. Ability to provide informed consent.
  8. Willing and able to comply with all study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Second primary malignancy that is clinically detectable at the time of consideration for study enrolment.
  2. Likelihood to require steroid treatment during the period of the clinical trial.
  3. Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples.
  4. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  5. Administration of any other cell therapy, including NK, CIK, DC, CTL, CAR- T, stem cells or combined therapy of the kind within 28 days prior to start of treatment.
  6. Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    HBV/ TCR T cell infusion

    Autologous T cells with HBV antigen-specific TCR

    Biological: TCR-T cells

Interventions

  • BiologicalTCR-T cells

    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.

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What researchers measure

Primary outcomes

  1. Safety evaluation of the TCR-T treatment

    Incidence of adverse events/serious adverse events

    Time frame: Start of Treatment until 28 days post last dose

Secondary outcomes

  1. 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.

    Time frame: Start of treatment until disease progression, and subsequent follow up up to 24 months post treatment.

  2. Progression-free survival (PFS)

    1-year PFS is measured by the number of patients with stable disease after 1 year, using RECIST v1.1.

    Time frame: Start of treatment until disease progression, and at 6-month and 1-year.

  3. 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.

    Time frame: Start of treatment until disease progression, and at 6-month and 1-year.

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Study locations

1 site
  • The First Affiliated Hospital of Sun-Yat Sen University
    Guangzhou, Guangdong 510080, China
08

References and documents

Publications

  • 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. PubMed 30711630 ↗
  • 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. PubMed 25308176 ↗
  • 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. PubMed 21145860 ↗
  • 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. PubMed 23941866 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04677088
Lead sponsor
Xiaoshun He
Collaborators
Lion TCR Pte. Ltd.
Responsible party
Xiaoshun He (MD., First Affiliated Hospital, Sun Yat-Sen University) — Sponsor-investigator
First posted
Dec 21, 2020
Start date
Mar 29, 2018
Primary completion
Feb 18, 2020
Completion
Dec 2021 (estimated)
Last update
Dec 21, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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