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New treatment option for Hepatocellular Carcinoma
Official title Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)
ClinicalTrials.gov ID: NCT04745403
What this study is testing
What is mRNA HBV/TCR T-cells?
mRNA HBV/TCR T-cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 75
You may be able to join if
- 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...
- Serum HBsAg positivity
- Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)
- Life expectancy of at least 3 months
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.