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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04745403
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : July 1, 2022
Information provided by (Responsible Party):
Lion TCR Pte. Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: mRNA HBV/TCR T-cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Tolerability Study of Redirected HBV-Specific T Cells in Patients With Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (SAFE-T-HBV)
Actual Study Start Date : May 20, 2022
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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.

Primary Outcome Measures :
  1. Safety evaluation of mRNA HBV/TCR T-cell treatment [ Time Frame: Start of treatment until 28 days post last dose ]
    Based on incidence and severity of adverse events

  2. Analysis of modifications of tumour microenvironment caused by mRNA HBV/TCR T-cell treatment [ Time Frame: Start of treatment until end of study ]
    Histological staining using biopsy and analysis of serum factors such as cytokines and chemokines

Secondary Outcome Measures :
  1. Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment [ Time Frame: Up to 4 years ]
    Objective response rate (ORR)

  2. Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment [ Time Frame: Up to 4 years ]
    Progression free survival (PFS)

  3. Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment [ Time Frame: Up to 4 years ]
    Overall survival (OS)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  6. 7. 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

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 identifier (NCT number): NCT04745403

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Contact: Royce Fam 69260818

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Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Thinesh L Krishnamoorthy    62223322   
Principal Investigator: Thinesh L Krishnamoorthy         
Sponsors and Collaborators
Lion TCR Pte. Ltd.
Publications of Results:
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Responsible Party: Lion TCR Pte. Ltd. Identifier: NCT04745403    
Other Study ID Numbers: LTCR-HCC-3-3
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: July 1, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lion TCR Pte. Ltd.:
Hepatitis B virus
Hepatocellular Carcinoma
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases