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NOT YET RECRUITING
NCT05195294
PHASE2

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

Sponsor: Lion TCR Pte. Ltd.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2025-03

Completion Date

2028-12

Last Updated

2025-03-10

Healthy Volunteers

No

Interventions

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