NCT06961617RecruitingPhase 1
Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
Safety and Efficacy of Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 8 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a single center and open-label study to determine the safety and efficacy of mRNA HBV-TCR redirected T-cells in HBV-related HCC who are not amenable to/failed conventional treatment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 6 May 2025
- Start date
- 1 Jun 2024
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Lion TCR Pte. Ltd.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06961617
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 1 Jun 2024 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Serum HBV DNA levels ≥ 200 IU/ml at screening
- Serum HBsAg levels ≥ 10,000 IU/ml at screening
Other
- Brain metastasis
- Women who are pregnant or breast-feeding
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gaobo Boren Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.