OncoMatch/Clinical Trials/NCT04745403
Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)
Is NCT04745403 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies mRNA HBV/TCR T-cells for hepatocellular carcinoma.
Treatment: mRNA HBV/TCR T-cells — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: immune checkpoint inhibitor
Use of immune checkpoint inhibitors and/or tyrosine kinase inhibitor (TKI) within 5 half-lives of the drug prior to baseline liver biopsy procedure
Cannot have received: tyrosine kinase inhibitor
Use of immune checkpoint inhibitors and/or tyrosine kinase inhibitor (TKI) within 5 half-lives of the drug prior to baseline liver biopsy procedure
Cannot have received: RFA/TACE
Last RFA/TACE treatment within 3 months prior to first LioCyx-M infusion
Cannot have received: Y90 therapy
Last Y90 therapy treatment within 6 months prior to first dose of mRNA HBV/TCR T-cells
Cannot have received: cytotoxic chemotherapy
Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
Cannot have received: hormonal therapy
Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
Cannot have received: immunotherapy
Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
Cannot have received: investigational product
Use of any investigational product (IP) or investigational medical device within 30 days of study drug administration
Lab requirements
Liver function
non-cirrhotic or compensated cirrhosis child-pugh a (5 - 6 points)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04745403 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immune checkpoint inhibitor, tyrosine kinase inhibitor, RFA/TACE disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger and at least 21 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages