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 :
Not yet recruiting
First Posted : February 9, 2021
Last Update Posted : February 9, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatocellular Carcinoma | Drug: mRNA HBV/TCR T-cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 5 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1 Safety and Tolerability Study of Redirected HBV-Specific T Cells in Patients With Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (SAFE-T-HBV) |
Estimated Study Start Date : | October 1, 2021 |
Estimated Primary Completion Date : | July 1, 2022 |
Estimated Study Completion Date : | December 31, 2022 |

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 TCR-T treatment [ Time Frame: Start of treatment until 28 days post last dose ]Based on assessments of adverse events (AEs) and serious AEs
- Analysis of modifications of tumour microenvironment caused by TCR-T treatment using biopsy samples [ Time Frame: Start of treatment until 14 days post last dose ]Based on immune gene expression changes determined by RNA sequencing
- Analysis of modifications of tumour microenvironment caused by TCR-T treatment using blood samples [ Time Frame: Start of treatment until 14 days post last dose ]Based on changes in level of serum cytokines

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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 |
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
- Detectable HBV DNA integrations in the HCC tumour biopsy
- Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)
- HLA class 1 profile matching HLA-class I restriction element of the available T cell receptors (restricted by HLA-A0201, HLA-B5801, HLA-Cw0801)
- Life expectancy of at least 3 months
- Serum anti HBV core antibody positive (at any historical time)
- Adequate organ function as defined below: a. Differential white blood counts within normal reference ranges b. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 150 IU/ml c. Total conjugated serum bilirubin ≤ upper limit normal (ULN) d. eGFR ≥ 60ml/minute e. Hemoglobin > 10.0 mg/ dl f. Platelet count ≥ 100,000/ μl
- Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
- Willing to undergo biopsy of non-tumour and tumour liver tissue before and after treatment
- Sexually active subjects must be willing to use an acceptable method of contraception such as double barrier contraception during treatment and for 28 days after the last dose of study drug
- Females of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have been in menopause at least 2 years, or had tubal ligation at least 1 year prior to Screening, or who have had total hysterectomy
- Willing and able to comply with all study procedures
Exclusion Criteria:
- Brain metastasis
- Second primary malignancy that is clinically detectable at the time of consideration for study enrolment
- Use of checkpoint inhibitors within 6 months of baseline liver biopsy procedure
- Alterations of concomitant medications within 3 months of baseline liver biopsy procedure.
- Likelihood to require any immunosuppressive treatments during the period of the clinical trial.
- Patient's last RFA/TACE, or Y90 therapy is less than 3 and 6 months ago, respectively.
- 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
- Poorly controlled medical illness that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
- Uncontrolled hypertension, defined as systolic blood pressure >160 mmHg or diastolic pressure >110 mmHg, despite optimal medical management
- 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
- Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of study results.
- 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 | |
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: | February 9, 2021 |
Last Verified: | February 2021 |
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 |