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RecruitingNCT04745403SAFE-T-HBVUpdated Nov 18, 2023

Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)

A Phase 1 interventional study of mRNA HBV/TCR T-cells in Hepatocellular Carcinoma, sponsored by Lion TCR Pte. Ltd.. Recruiting at 1 site in Singapore. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Lion TCR Pte. Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started May 2022; still recruiting 4 years 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
21 Years to 75 Years
Sex
All
01

Study summary

This is a single center, single arm and open-label study to determine the safety of mRNA modified HBV-TCR redirected T-cells and to analyze the changes in tumor microenvironment caused by these HBV-TCR redirected T-cells in subjects with HBV-related HCC who are not amenable to/failed conventional treatment.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Hepatitis B virus
  • Hepatocellular Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's planned enrollment of 10 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Lion TCR Pte. Ltd. is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  2. Presence of primary hepatocellular carcinoma in the liver with presence of measurable tumour by RECIST 1.1 criteria, that is not amenable to, or failed, conventional treatment options
  3. Serum HBsAg positivity
  4. Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)
  5. Life expectancy of at least 3 months
  6. HLA class 1 profile matching HLA-class I restriction element of the available T cell receptors (restricted by either HLA-A*02:01 or HLA-A*24:02).

Key Exclusion Criteria:

  1. Brain metastasis
  2. Second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer and superficial bladder tumors
  3. Use of immune checkpoint inhibitors and/or tyrosine kinase inhibitor (TKI) within 5 half-lives of the drug prior to baseline liver biopsy procedure
  4. Alterations of concomitant medications which could potentially cause drug induced liver injury and affect liver biopsy result within 3 months of baseline liver biopsy procedure.
  5. Likelihood to require any immunosuppressive treatments during the period of the clinical trial.
    1. Last RFA/TACE treatment within 3 months prior to first LioCyx-M infusion; Last Y90 therapy treatment within 6 months prior to first dose of mRNA HBV/TCR T-cells
  7. Decompensated cirrhosis Child-Pugh B or C (7 - 15 points)
  8. Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
  9. Use of any investigational product (IP) or investigational medical device within 30 days of study drug administration
  10. Serum HBV DNA levels ≥ 200 IU/ml at screening
  11. Serum HBsAg levels ≥ 10,000 IU/ml at screening
  12. Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
  13. Any condition or active infections which, in the investigator's opinion, makes the subject unsuitable for trial participation
  14. Women who are pregnant or breast-feeding
05

Study design

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

Study arms

  • Experimental
    mRNA HBV/TCR T-cells

    Escalating regime from 1x10e5 to 5-10x10e6 cells/kg bodyweight (BW) every 2 weeks.

    Drug: mRNA HBV/TCR T-cells

Interventions

  • DrugmRNA HBV/TCR T-cells

    Study Infusion The first dose of mRNA HBV-TCR T-cells at dose 1x10e5/kg BW will be infused on Day 0, and subsequently incremental doses on Day 14 and 28, up to the dose of 5-10x10e6/kg BW.

06

What researchers measure

Primary outcomes

  1. Safety evaluation of mRNA HBV/TCR T-cell treatment

    Based on incidence and severity of adverse events

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

  2. Analysis of modifications of tumour microenvironment caused by mRNA HBV/TCR T-cell treatment

    Histological staining using biopsy and analysis of serum factors such as cytokines and chemokines

    Time frame: Start of treatment until end of study

Secondary outcomes

  1. Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment

    Objective response rate (ORR)

    Time frame: Up to 4 years

  2. Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment

    Progression free survival (PFS)

    Time frame: Up to 4 years

  3. Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment

    Overall survival (OS)

    Time frame: Up to 4 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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 ↗
  • Kah J, Koh S, Volz T, Ceccarello E, Allweiss L, Lutgehetmann M, Bertoletti A, Dandri M. Lymphocytes transiently expressing virus-specific T cell receptors reduce hepatitis B virus infection. J Clin Invest. 2017 Aug 1;127(8):3177-3188. doi: 10.1172/JCI93024. Epub 2017 Jul 24. PubMed 28737510 ↗
  • 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04745403
Lead sponsor
Lion TCR Pte. Ltd.
Responsible party
Sponsor
First posted
Feb 9, 2021
Start date
May 20, 2022
Primary completion
Jul 1, 2026 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Nov 18, 2023

Study contacts

Royce Fam
Contact
royce.fam@liontcr.com
69260818

Oversight

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

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