Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479616
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
A Long-term Follow-up Study in Participants Who Received CS-101
Sponsor:
Childrens Hospital of Fudan University
Organization:
Childrens Hospital of Fudan University
Study Overview
Official Title:
A Long-term Follow-up Study Evaluating the Safety and Efficacy of Subjects With β-thalassemia Treated With Base-edited Autologous Hematopoietic Stem Cell CS-101 Transplantation
Status:
RECRUITING
Status Verified Date:
2024-06
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 study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-03 NCT06065189
Detailed Description:
This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-03 NCT06065189
Subjects in the CS-101-03 study will be entered into long-term follow-up of this study up to 2 years post-infusion at the completion of the last 6-month follow-up visit after treatment with CS-101 Injection
Subjects in the CS-101-03 study will be entered into long-term follow-up of this study up to 2 years post-infusion at the completion of the last 6-month follow-up visit after treatment with CS-101 Injection
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