Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749641
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2021-02-03
Brief Title:
Neoantigen Vaccine Therapy Against H33-K27M Diffuse Intrinsic Pontine Glioma
Sponsor:
Yang Zhang
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Enhanced Histone H33-K27M Neoantigen Vaccine Therapy Against Diffuse Intrinsic Pontine Glioma ENACTING- A Phase I Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-07
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:
ENACTING
Brief Summary:
Diffuse intrinsic pontine gliomas DIPGs which diffusely occupy the pons of brainstem are the deadliest primary brain cancer in children Biopsy for pathology plus radiotherapy remains the current standard-of-care treatment that is minimal effective Thus the median overall survival after diagnosis is just 10 months Recent studies have identified a lysine 27-to-methionine K27M somatic mutation at histone H3 variant H33 as a feature mutation in DIPGs Several preclinical studies have already demonstrated H33-K27M as a promising target for immunotherapy The researched vaccine is a cancer-treatment vaccine containing an H33-K27M targeted neoantigen peptide that can be taken up by antigen-presenting cells APCs APCs can present the peptide with the major histocompatibility complex MHC molecules on cell surface thereby activating neoantigen-specific T cells and triggering corresponding cytotoxic T cell immune responses to eliminate H33-K27M-expressing DIPG cells The main goal of this study is investigating the safety and preliminary efficacy of the vaccine in treating newly-diagnosed DIPGs when the vaccine is administered in combination with the standard-of-care treatment
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