Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04741984
Status:
WITHDRAWN
Last Update Posted:
2023-05-15
First Post:
2021-02-01
Brief Title:
Monocyte Antigen Carrier Cells for Newly Diagnosed GBM
Sponsor:
Michael Gunn
Organization:
Duke University
Study Overview
Official Title:
The DEMAND Study Dose Escalation Study of Monocyte Antigen Carrier Cells for Newly Diagnosed Glioblastoma With Unmethylated MGMT Gene Promoter
Status:
WITHDRAWN
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to need to proceed with procedural changes with goals of improving the technical and economic feasibility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEMAND
Brief Summary:
The primary purpose of this study is to determine the maximum tolerated dose MTD of MT-201-GBM pp65CMV antigen monocytes that will be administered to patients newly diagnosed with a type of brain tumor called glioblastoma GBM that has an unmethylated MGMT O6-methylguanine-DNA methyltransferase MGMT gene promoter
Detailed Description:
The investigational vaccine MT-201-GBM in this study is made from a type of immune cell called monocytes which have been engineered to express a cytomegalovirus CMV protein
The monocyte vaccines are made from the patients own cells which are collected through a procedure called leukapheresis During leukapheresis the patients blood is collected into a machine that removes white blood cells and then returns the remainder of the blood back to the individual The leukapheresis procedure is not typically associated with any discomfort or pain The white blood cells collected from leukapheresis are used to generate the patients monocyte vaccine After leukapheresis patients receive standard radiation therapy combined with temozolomide for about 6 weeks followed by one cycle of temozolomide for 21 days About 2 days later patients will receive the first monocyte vaccine followed by 2 more monocyte vaccines every 4 weeks
The monocyte vaccines are made from the patients own cells which are collected through a procedure called leukapheresis During leukapheresis the patients blood is collected into a machine that removes white blood cells and then returns the remainder of the blood back to the individual The leukapheresis procedure is not typically associated with any discomfort or pain The white blood cells collected from leukapheresis are used to generate the patients monocyte vaccine After leukapheresis patients receive standard radiation therapy combined with temozolomide for about 6 weeks followed by one cycle of temozolomide for 21 days About 2 days later patients will receive the first monocyte vaccine followed by 2 more monocyte vaccines every 4 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P01CA225622 | NIH | None | httpsreporternihgovquickSearch5P01CA225622 |