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

RecruitingPhase 1Ages 18 Years - 70 YearsAllLion TCR Pte. Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค1 * 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 โ‰ฅ 200 IU/ml at screening * Serum HBsAg levels โ‰ฅ 10,000 IU/ml at screening * Women who are pregnant or breast-feeding
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What it tests

  • LioCyx-M, HBV antigen-specific TCR-redirected T cells
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Where

1 site
Gaobo Boren Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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