MedTrace Logo

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

NCT05905731 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-06-15

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • Beijing 302 Hospital

    lead OTHER

Principal Investigators

  • Fu-Sheng Wang, MD · Beijing 302 Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05905731 on ClinicalTrials.gov