Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05685004
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2022-12-22
Brief Title:
Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme GBM
Sponsor:
TVAX Biomedical
Organization:
TVAX Biomedical
Study Overview
Official Title:
Randomized Phase 2b Study of Safety And Efficacy Of TVI-Brain-1 Combined With Conformal Radiotherapy And Temozolomide Vs Standard Therapy In Newly Diagnosed MGMT Negative Glioblastoma Multiforme GBM
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized study is designed to compare the combination of TVI-Brain-1 immunotherapy and standard therapy compared to standard therapy alone as a treatment for newly diagnosed MGMT unmethylated glioblastoma patients The patients own cancer cells collected after surgery are combined into a vaccine to produce an immune response that significantly increases the number of cancer neoantigen-specific effector T cell precursors in the patients body These cancer neoantigen-specific T cells are harvested from the blood subsequently stimulated and expanded and infused back into the patient
Detailed Description:
This randomized study is designed to compare the combination of TVI-Brain-1 immunotherapy and standard therapy compared to standard therapy alone as a treatment for newly diagnosed MGMT unmethylated glioblastoma patients The general procedures include the collection and testing of cancer tissue samples after surgery and chemoradiation therapy radiation and temozolomide For the patients randomized into the investigational study treatment group they will also receive two vaccinations created from their own cancer cells undergo leukapheresis to collect immune T-cells from their blood and transfer of those activated effector T-cells after chemoradiation therapy All patients are followed with MRIs at follow-up visits
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