Clinical Trial

A Phase 1 Study of Gene-modified Autologous Hematopoietic Stem Cell (BD211) Treating β-thalassemia Major

Recruiting Phase 1
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Summary
This study will be intented to evaluate the safety, tolerability, and engraftment efficacy after myeloablative preconditioning and transplantation of autologous CD34+ hematopoietic stem cells transduced with a lentiviral vector encoding the human βA-T87Q-globin gene in patients with transfusion-dependent (TDT) β-thalassemia.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-06-13.
Trial Details
NCT Number NCT06465550
Lead Sponsor Shanghai BDgene Co., Ltd.
Conditions β-thalassemia
Enrollment 9 participants
Start Date 2024-01-05
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2024-06-24