Tests modified immune cells in adults with hepatitis B-related liver cancer
Tests modified immune cells in adults with liver cancer caused by hepatitis B.
Plain-language title generated from the registry record
Registry title: Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)
Key facts
- Where
- Singapore, SingaporeSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 75 years old?
Source: NCT04745403, who can take part
Where in Singapore
- Singapore General HospitalSingapore, SingaporeTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lion TCR Pte. Ltd.
- Trial code
- NCT04745403
- Record updated
- 18 November 2023
- Original description
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.Read full original descriptionShow less
Safety and Tolerability Study of Redirected HBV-Specific T Cells in Patients With Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (SAFE-T-HBV)
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.
Inclusion: 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).
Exclusion: 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; 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; 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; 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; 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; Serum HBV DNA levels ≥ 200 IU/ml at screening; Serum HBsAg levels ≥ 10,000 IU/ml at screening; Brain metastasis; Likelihood to require any immunosuppressive treatments during the period of the clinical trial; Decompensated cirrhosis Child-Pugh B or C (7 - 15 points); Women who are pregnant or breast-feeding.