Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389591
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-24
Brief Title:
RNA-Lipid Particle RNA-LP Vaccines for Recurrent Adult Glioblastoma GBM
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
A Phase I Study of RNA-Lipid Particle RNA-LP Vaccines for Recurrent Adult Glioblastoma GBM
Status:
NOT_YET_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 is a Phase I study to demonstrate the manufacturing feasibility and safety and to determine the maximum tolerated dose MTD of RNA-LP vaccines in adult patients with recurrent glioblastoma
Detailed Description:
This is a first in human Phase I study of RNA-LP vaccines for recurrent adult glioblastoma Patients will be randomized 11 to receive RNA-LP starting either before Arm 1 or after tumor biopsyresection Arm 2
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