Treatment of liver cancer using personalized T cell therapy
Safety and Efficacy of Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
PHASE1 · Lion TCR Pte. Ltd. · NCT06961617
This study is testing a new personalized T cell therapy for patients with advanced liver cancer related to hepatitis B who haven't had success with other treatments.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Lion TCR Pte. Ltd. (industry) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06961617 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of autologous HBV-TCR T cell therapy, known as LioCyx-M, for patients with hepatocellular carcinoma (HCC) related to hepatitis B virus who have not responded to conventional treatments. The study is open-label and conducted at a single center, focusing on patients with advanced HCC who have failed at least one line of systemic therapy. Participants will receive T cells that are specifically redirected to target HBV antigens, aiming to improve treatment outcomes for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed HCC who have failed previous treatments and have specific HLA profiles.
Not a fit: Patients with brain metastasis or those currently receiving other anti-tumor therapies will not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced liver cancer who have limited alternatives.
How similar studies have performed: While this approach is innovative, similar studies using T cell therapies for cancer treatment have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HCC diagnosis confirmed by histology/ cytology or clinically * HCC that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies * Has failed at least one line of systemic therapy for HCC * ECOG performance status ≤1 * Serum HBsAg positivity * Child-Pugh A (5 - 7 points) * Life expectancy of at least 1 year * HLA profile: HLA-A\*02:01 or HLA-A\*24:02 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 * Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, TKI therapy, and immunotherapy. * Use of any investigational product (IP) or investigational medical device within 28 days of study drug administration * Serum HBV DNA levels ≥ 200 IU/ml at screening * Serum HBsAg levels ≥ 10,000 IU/ml at screening * Women who are pregnant or breast-feeding
Where this trial is running
Beijing
- Gaobo Boren Hospital — Beijing, China (RECRUITING)
Study contacts
- Study coordinator: Wang Zhe
- Email: zhe.wang@liontcr.com
- Phone: +86 15902091916
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.
Conditions: Hepatocellular Carcinoma