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OncoMatch/Clinical Trials/NCT04745403

Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)

Is NCT04745403 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies mRNA HBV/TCR T-cells for hepatocellular carcinoma.

Phase 1RecruitingLion TCR Pte. Ltd.NCT04745403Data as of May 2026

Treatment: mRNA HBV/TCR T-cellsThis 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.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

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.

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