LioCyx-M T Cell Therapy for Hepatocellular Carcinoma: A Phase 1 Clinical Trial

This groundbreaking Phase 1 clinical trial investigates the safety and efficacy of LioCyx-M, an innovative autologous HBV-TCR T cell therapy for treating hepatocellular carcinoma (HCC). The experimental treatment utilizes the patient's own T cells that are genetically engineered to target HBV antigens present on HCC tumor cells.

The study will enroll approximately 10 adult participants with advanced HCC who meet specific eligibility criteria, including confirmed HCC diagnosis, HBsAg positivity, and failure of at least one prior systemic therapy. Key exclusion criteria include brain metastasis, high HBV DNA levels, and concurrent anti-tumor therapies.

Primary objectives of the trial include:

• Safety assessment through monitoring of adverse events
• Evaluation of anti-tumor efficacy via objective response rate (ORR)

Secondary endpoints include:

• Duration of response (DoR)
• Progression-free survival (PFS)
• Overall survival (OS)

Participants will receive weekly intravenous infusions of LioCyx-M at a dose of 5-10 x 10^6 cells/kg body weight. The open-label, single-arm study design allows for close monitoring of treatment effects in this first-in-human investigation of this novel cellular therapy approach for HCC.

Conducted by Lion TCR Pte. Ltd. in collaboration with Beijing GoBroad Hospital, this trial represents an important step in developing targeted immunotherapies for HBV-associated hepatocellular carcinoma. The study is scheduled to run from June 2024 through December 2027, with results potentially paving the way for larger clinical trials of this promising treatment modality.