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NCT05905731Not yet recruiting

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

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
Beijing 302 HospitalPhase 1ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
Chronic Hepatitis B
Drug/Device/Intervention
TCR-T
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Beijing 302 Hospital
Location
Beijing, China
Timeline & enrollment
Phase
Phase 1
Start date
Jun 01, 2023
End date
Jun 01, 2026
Enrollment
20 participants
Primary outcome

Safety evaluation of HBV-TCR T cell treatment

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.

ICD-10 classifications
Acute hepatitis BChronic viral hepatitis B without delta-agentAcute delta-(super)infection in chronic hepatitis BChronic viral hepatitis B without delta-agent : other and unspecified phaseChronic viral hepatitis B without delta-agent : immune-tolerant phase
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05905731
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05905731 through Pure Global AI's free database. This Phase 1 trial is sponsored by Beijing 302 Hospital and is currently Not yet recruiting. The study focuses on Chronic Hepatitis B. Target enrollment is 20 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.