Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma

Summary

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.

Eligibility

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

Conditions4

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