Clinical Trial

Evaluating Safety and Efficacy of Lentiviral-transduced CD34+ HSCs in Β-thalassaemia Patients.

Recruiting Phase 1
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Record status
This record was last updated October 23, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a single-arm, open label, multi-center, single-dose Phase 1 clinical trial in subjects with transfusion dependent β-thalassaemia. The study aims to evaluate the safety and efficacy of autologous lentiviral-transduced CD34+ human hematopoietic stem cells (hHSCs) using the gene therapy product HGI-001.
Trial Details
NCT Number NCT06655662
Lead Sponsor Shenzhen Hemogen
Conditions Β-thalassemia
Enrollment 8 participants
Start Date 2024-06-12
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-23