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Autologous T-cells Transfected With mRNA Encoding HBV-TCR T Cell Therapy in Combination With NUC for Chronic Hepatitis B
Sponsor: Beijing 302 Hospital
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.
Official title: Study Evaluating the Safety and Efficacy of Autologous T-cells Transfected With mRNA Encoding Hepatitis-B Virus (HBV)-Antigen-specific T Cell Receptor (TCR) in Combination With Nucleos(t)Ide Analogue (NUC) for Chronic Hepatitis B
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-06-01
Completion Date
2026-06
Last Updated
2023-06-15
Healthy Volunteers
No
Conditions
Interventions
TCR-T
Stage-1: Patients will receive three biweekly HBV-TCR T cell infusions at escalating doses, ranging from 1 x 10\^5 cells/kg to 5 x 10\^6 cells/kg bodyweight (by IV infusion). Patients are to remain on existing HBV NUC treatment. Stage-2: Patients will receive three biweekly HBV-TCR T cell infusions at maximum dose as determined in Stage-1 study. Patients are to remain on existing HBV NUC treatment.
Locations (1)
The Fifth Medical Center of PLA General Hospital
Beijing, China