NCT05195294

Study of HBV-TCR T Cells (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for HBV-related HCC

A Multi-center, Phase 2 Study for Autologous T Cells Transfected With mRNA Encoding HBV Antigen-specific TCR (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for Advanced HBV-related Hepatocellular Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Lion TCR Pte. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label and multi-center Phase 2 study to evaluate the safety and efficacy of autologous T-cells transfected with mRNA encoding Hepatitis-B virus (HBV)-antigen-specific T cell receptor (TCR) (LioCyx-M) as monotherapy or as combination with lenvatinib for the treatment of advanced HBV-related hepatocellular carcinoma (HCC).

Conditions

• Hepatocellular Carcinoma
• Liver Cancer, Adult
• Liver Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	LioCyx-M	HBV antigen specific TCR redirected T cells
DRUG	Lenvatinib	12 mg once daily for patients ≥60 kg, 8 mg for patients \<60kg by oral

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2022-01-18
• Last updated: 2025-03-10

Regulatory

• FDA-regulated drug study