drugset / Trial / NCT05195294
Study of HBV-TCR T Cells (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for HBV-related HCC
Non-randomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2025-03
- Primary completion
- 2026-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 8 mg | Oral |
| Subject | Lenvatinib | Small molecule | 12 mg | Oral |
| Subject | LioCyx-M | Cell therapy | — | — |