This is a single center and open-label study to determine the safety and efficacy of mRNAHBV-TCR redirected T-cells in HBV-related HCC who are not amenable to/failed conventionaltreatment.
Not Provided
Drug: LioCyx-M, HBV antigen-specific TCR-redirected T cells
Via intravenous (IV) infusion
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
Gaobo Boren Hospital
Beijing 1816670, China
Investigator: Wang Zhe
Contact: +86 15902091916
zhe.wang@liontcr.com
Wang Zhe
+86 15902091916
zhe.wang@liontcr.com
Tina Wang, Study Director
Lion TCR Pte. Ltd.