Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371040
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-17
Brief Title:
Safety and Efficacy of CD19-BCMA Targeted CAR-T Therapy for Refractory Generalized Myasthenia Gravis
Sponsor:
Ting Chang MD
Organization:
Tang-Du Hospital
Study Overview
Official Title:
Evaluate the Safety and Efficacy of CD19-BCMA Targeted CAR-T Therapy for Refractory Generalized Myasthenia Gravis A Single-center Open-label Single-arm Dose-finding Study
Status:
RECRUITING
Status Verified Date:
2024-08
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 study is a single-center open-label single-arm dose-exploration study to evaluate the safety and preliminary effectiveness of CD19-BCMA CAR-T in the treatment of refractory generalized myasthenia gravis The study is a dose escalation trial in adult refractory systemic MG patients The Keyboard method will be used to perform dose escalation to explore the maximum tolerated dose MTD A total of 12 MG patients who meet the inclusion criteria are expected to be recruited
Detailed Description:
None
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