Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05938387
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-06-06
Brief Title:
Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma
Sponsor:
CureVac
Organization:
CureVac
Study Overview
Official Title:
A Phase 1 Dose-Finding Study to Evaluate Safety and Tolerability of CVGBM in Patients With Surgically Resected Glioblastoma GBM or Astrocytoma With a Molecular Signature of Unmethylated Glioblastoma
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 an open-label first-in-human dose-escalation study of CV09050101 mRNA vaccine CVGBM in patients with newly diagnosed MGMT-unmethylated Glioblastoma GBM Patients with isocitrate dehydrogenase IDH-wildtype astrocytoma with a molecular signature of unmethylated GBM are also eligible
After surgical resection and completion of radiotherapy for GBM with or without chemotherapy patients will receive CVGBM ie as monotherapy after radiotherapy with or without chemotherapy
The study consists of a dose-escalation part Part A which completes enrollment in February 2024 and a dose-expansion part Part B which is anticipated to begin enrolling in JuneJuly 2024
Patients will receive a total of 7 administrations of CVGBM on Days 1 8 15 29 43 57 and 71 At the discretion of the Investigator in alignment with the Sponsors medical monitor the vaccinations may continue beyond Day 71 every 6 weeks until one year after the first CVGBM vaccination or upon disease progression or undue toxicity
After surgical resection and completion of radiotherapy for GBM with or without chemotherapy patients will receive CVGBM ie as monotherapy after radiotherapy with or without chemotherapy
The study consists of a dose-escalation part Part A which completes enrollment in February 2024 and a dose-expansion part Part B which is anticipated to begin enrolling in JuneJuly 2024
Patients will receive a total of 7 administrations of CVGBM on Days 1 8 15 29 43 57 and 71 At the discretion of the Investigator in alignment with the Sponsors medical monitor the vaccinations may continue beyond Day 71 every 6 weeks until one year after the first CVGBM vaccination or upon disease progression or undue toxicity
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-501423-25 | EUDRACT_NUMBER | None | None |