Using modified T cells to treat liver cancer related to hepatitis B
Safety and Tolerability Study of Redirected HBV-Specific T Cells in Patients With Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (SAFE-T-HBV)
This study is testing a new treatment using modified immune cells to see if they can help people with liver cancer caused by hepatitis B who haven't had success with other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | Lion TCR Pte. Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Singapore) |
| Trial ID | NCT04745403 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the safety of mRNA modified HBV-TCR redirected T-cells in patients with hepatocellular carcinoma (HCC) related to hepatitis B virus who have not responded to conventional treatments. It is a single-center, open-label trial that will analyze the effects of these modified T-cells on the tumor microenvironment. Participants must have measurable tumors and specific HLA class 1 profiles to qualify for the treatment. The study focuses on patients with a performance status of 1 or less and a life expectancy of at least three months.
Who should consider this trial
Good fit: Ideal candidates are patients with primary hepatocellular carcinoma who are HBsAg positive and have not responded to conventional treatments.
Not a fit: Patients with brain metastasis or those with other clinically detectable malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with HBV-related HCC who have limited alternatives.
How similar studies have performed: While this approach is innovative, similar studies using T-cell modifications have shown promise in other cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Singapore
- Singapore General Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Royce Fam
- Email: royce.fam@liontcr.com
- Phone: 69260818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.