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Autologous T-cells Transfected With mRNA Encoding HBV-TCR T Cell Therapy in Combination With NUC for Chronic Hepatitis B - Trial NCT05905731

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.

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NCT05905731
Phase 1
Not yet recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT05905731
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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

Study Focus

Chronic Hepatitis B

TCR-T

Interventional

biological

Sponsor & Location

Beijing 302 Hospital

Beijing, China

Timeline & Enrollment

Phase 1

Jun 01, 2023

Jun 01, 2026

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 B
Chronic viral hepatitis B without delta-agent
Acute delta-(super)infection in chronic hepatitis B
Chronic viral hepatitis B without delta-agent : other and unspecified phase
Chronic viral hepatitis B without delta-agent : immune-tolerant phase

Data Source

ClinicalTrials.gov

NCT05905731

Non-Device Trial