Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)
Recruiting · NCT04745403 · Interventional (participants receive a specific treatment) · Lead sponsor: Lion TCR Pte. Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
mRNA HBV/TCR T-cells
What this trial is about
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.
Who can take part
Age range
21 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Singapore General Hospital - Singapore, Singapore