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Clinical Trials in Singapore / NCT04745403
Recruiting Phase 1

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

NCT04745403 · tracked via the Priya Life Science Singapore tracker
Sponsor
Lion TCR Pte. Ltd
Phase
Phase 1
Started
2022-05-20
Last updated
2023-11-18

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

mRNA HBV/TCR T-cells

mRNA HBV/TCR T-cells: Study Infusion The first dose of mRNA HBV-TCR T-cells at dose 1x10e5/kg BW will be infused on Day 0, and subsequently incremental doses on Day 14 and 28, up to the dose of 5-10x10e6/kg BW.

Study summary

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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
75 Years
Healthy volunteers
No
Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 2. 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 3. Serum HBsAg positivity 4. Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points) 5. Life expectancy of at least 3 months 6. 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: 1. Brain metastasis 2. 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 3. Use of immune checkpoint inhibitors and/or tyrosine kinase inhibitor (TKI) within 5 half-lives of the drug prior to baseline liver biopsy procedure 4. 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. 5. Likelihood to require any immunosuppressive treatments during the period of the clinical trial. 6. 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 7. Decompensated cirrhosis Child-Pugh B or C (7 - 15 points) 8. Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy. 9. Use of any investigational product (IP) or investigational medical device within 30 days of study drug administration 10. Serum HBV DNA levels ≥ 200 IU/ml at screening 11. Serum HBsAg levels ≥ 10,000 IU/ml at screening 12. Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples 13. Any condition or active infections which, in the investigator's opinion, makes the subject unsuitable for trial participation 14. Women who are pregnant or breast-feeding

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Singapore General Hospital Singapore Singapore Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04745403 on ClinicalTrials.gov ↗ ← All trials in Singapore