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Clinical Trial 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.


Clinical Trial Description

This is an open-label, single-dose study of BD211 in patients with transfusion-dependent β-thalassemia aged 6 to 35 years. It is estimated that 10 subjects will be enrolled. BD211 is a gene modified gene therapy product designed to produce healthy β-globin in red blood cells in beta-thalassemia patients. The total follow-up duration was 24 months, the safe endpoints and effectiveness endpoints will be used to assess the safety and efficacy profiles in patients with transfusion-dependent β-thalassemia. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05776173
Study type Interventional
Source Shanghai BDgene Co., Ltd.
Contact Sujiang Zhang, M.D.
Phone +86-17717285030
Email zbruce.zhang@hotmail.com
Status Recruiting
Phase N/A
Start date August 10, 2023
Completion date October 2026

See also
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Not yet recruiting NCT04592458 - Safety and Efficacy Evaluation of β-globin Restored Autologous Hematopoietic Stem Cells in β-thalassemia Major Patients Phase 1
Withdrawn NCT01724138 - An Open Label Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of Deferasirox Administered to Chinese Patients With β-thalassemia Major Aged From 2 to Less Than 6 Years Old Phase 4
Completed NCT01745120 - A Study Evaluating the Safety and Efficacy of the LentiGlobin BB305 Drug Product in β-Thalassemia Major Participants Phase 1/Phase 2