A Study Evaluating the Safety and Efficacy of LentiRed Drug Product in Transfusion-dependent β-Thalassemia [TDT]
An Open Label Study Evaluating the Safety and Efficacy of Gene Therapy for Transfusion-dependent β-Thalassemia by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo With a LentiRed Lentiviral Vector (GMCN-508B Drug Product, Also Called LentiRed)
First Affiliated Hospital of Guangxi Medical University
5 participants
Feb 22, 2023
INTERVENTIONAL
Conditions
Summary
This is a single-arm, open label, single-dose study in subjects with transfusion dependent β-thalassaemia. The study will evaluate the safety and efficacy of autologous CD34+ Human Hematopoietic Stem Cells that was transduced with LentiRed Lentivrial vector.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
LentiRed Drug Product is administered by intravenous infusion following myeloablative conditioning with busulfan.
Locations(1)
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NCT05762510