Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV) (SAFE-T-HBV)
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ClinicalTrials.gov Identifier: NCT04745403 |
Recruitment Status :
Recruiting
First Posted : February 9, 2021
Last Update Posted : July 1, 2022
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Condition or disease | Intervention/treatment | Phase |
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Hepatocellular Carcinoma | Drug: mRNA HBV/TCR T-cells | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: mRNA HBV/TCR T-cells
Escalating regime from 1x10e5 to 5-10x10e6 cells/kg bodyweight (BW) every 2 weeks.
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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. |
- 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
- 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
- Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment [ Time Frame: Up to 4 years ]Objective response rate (ORR)
- Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment [ Time Frame: Up to 4 years ]Progression free survival (PFS)
- Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment [ Time Frame: Up to 4 years ]Overall survival (OS)

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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:
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- 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
- Serum HBsAg positivity
- Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)
- Life expectancy of at least 3 months
- 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:
- Brain metastasis
- 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
- Use of immune checkpoint inhibitors and/or tyrosine kinase inhibitor (TKI) within 5 half-lives of the drug prior to baseline liver biopsy procedure
- 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.
- Likelihood to require any immunosuppressive treatments during the period of the clinical trial.
- 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
- Decompensated cirrhosis Child-Pugh B or C (7 - 15 points)
- Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- Use of any investigational product (IP) or investigational medical device within 30 days of study drug administration
- Serum HBV DNA levels ≥ 200 IU/ml at screening
- Serum HBsAg levels ≥ 10,000 IU/ml at screening
- Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
- Any condition or active infections which, in the investigator's opinion, makes the subject unsuitable for trial participation
- Women who are pregnant or breast-feeding

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 ClinicalTrials.gov identifier (NCT number): NCT04745403
Contact: Royce Fam | 69260818 | royce.fam@liontcr.com |
Singapore | |
Singapore General Hospital | Recruiting |
Singapore, Singapore, 169608 | |
Contact: Thinesh L Krishnamoorthy 62223322 thinesh.l.krishnamoorthy@singhealth.com.sg | |
Contact thinesh.l.krishnamoorthy@singhealth.com.sg | |
Principal Investigator: Thinesh L Krishnamoorthy |
Responsible Party: | Lion TCR Pte. Ltd. |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hepatitis B virus Hepatocellular Carcinoma |
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |