Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04293185
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2020-02-12
Brief Title:
A Study Evaluating Gene Therapy With BB305 Lentiviral Vector in Sickle Cell Disease
Sponsor:
bluebird bio
Organization:
bluebird bio
Study Overview
Official Title:
A Phase 3 Study Evaluating Gene Therapy by Transplantation of Autologous CD34 Stem Cells Transduced Ex Vivo With the BB305 Lentiviral Vector in Subjects With Sickle Cell Disease
Status:
RECRUITING
Status Verified Date:
2024-07
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 non-randomized open-label multi-site single-dose Phase 3 study in approximately 35 adults and pediatric subjects 2 and 50 years of age with sickle cell disease SCD The study will evaluate hematopoietic stem cell HSC transplantation HSCT using bb1111 also known as LentiGlobin BB305 Drug Product for SCD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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