Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05762510
Status:
RECRUITING
Last Update Posted:
2023-05-09
First Post:
2022-01-06
Brief Title:
A Study Evaluating the Safety and Efficacy of LentiRed Drug Product in Transfusion-dependent β-Thalassemia TDT
Sponsor:
First Affiliated Hospital of Guangxi Medical University
Organization:
First Affiliated Hospital of Guangxi Medical University
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Subject participation for this study will be 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None