drugset / Trial / NCT05905731

Autologous T-cells Transfected With mRNA Encoding HBV-TCR T Cell Therapy in Combination With NUC for Chronic Hepatitis B

NCT05905731 ↗

Phase 1 Unknown 20 enrolled Beijing 302 Hospital
NaSingle-groupOpen-labelTreatment

Summary

This is a single center, single arm, open label study to assess the safety, tolerability and effectiveness of the autologous HBV specific T cell receptor (HBV-TCR) redirected T cells in patients with chronic hepatitis B with ongoing with nucleos(t)ide analogue (NUC) treatment. This study will be conducted sequentially starting with Stage-1, followed by Stage-2.

Timeline

Start
2023-06-01
Primary completion
2025-06
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject TCR-T Cell therapy 100000 cells/kg Intravenous
Subject TCR-T Cell therapy 5e+06 cells/kg Intravenous