Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342908
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-03-06
Brief Title:
A Vaccine Neoantigen-Targeted ppDC for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Pilot Study to Evaluate the Safety and Feasibility of Neoantigen-Targeted Dendritic Cell Vaccination in Diffuse Hemispheric Glioma H3 G34-Mutant
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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 phase I trial tests the safety and side effects and best dose of a vaccine neoantigen-target ppDC in treating patients with H3 G34-mutant diffuse hemispheric glioma Vaccines made from the patients own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells Giving neoantigen-targeted ppDC may be safe tolerable andor effective in treating patients with diffuse hemispheric glioma with a H3 G34 mutation
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the safety and feasibility of neoantigen-targeted ppDC in adult patients with diffuse hemispheric glioma DHG
SECONDARY OBJECTIVES
I To evaluate the immunogenicity of neoantigen-targeted ppDC in adult patients with DHG
II To determine whether neoantigen-targeted ppDC facilitates systemic T cell-mediated adaptive immune activation in DHG patients
III To determine whether neoantigen-targeted ppDC facilitates a target-specific anti-tumor T cell expansion in DHG patients
IV To determine whether pro-inflammatory phenotypic changes in systemic immune cell populations are detected in peripheral blood in response to neoantigen-targeted ppDC vaccination in DHG patients
EXPLORATORY OBJECTIVES
I To estimate the potential efficacy of neoantigen-targeted ppDC in DHG patients
II To correlate physiologic and metabolic magnetic resonance imaging MRI with systemic immunologic response after neoantigen-targeted ppDC in DHG patients
III To isolate and sequence immunodominant anti-tumor T cell T-cell receptor TCRs stimulated by neoantigen-targeted ppDC in DHG patients
IV To explore whether study participants demonstrating immune-reactive responses to neoantigen-targeted ppDC harbor significantly different gastrointestinal microbiota profiles in comparison to unresponsive participants
OUTLINE
Patients undergo leukapheresis 10 days prior to first injection Patients then receive ppDC intradermally ID with poly ICLC intramuscularly IM in both arms every 2 weeks Q2W for total 3 doses and then every 6 months for up to 3 doses Patients undergo magnetic resonance imaging MRI throughout the trial Patients also undergo blood sample collection throughout the trial in addition to stool sample collection during screening and on the trial
After completion of study treatment patients are followed up at 30 and 120 days and then up to 24 months
I To evaluate the safety and feasibility of neoantigen-targeted ppDC in adult patients with diffuse hemispheric glioma DHG
SECONDARY OBJECTIVES
I To evaluate the immunogenicity of neoantigen-targeted ppDC in adult patients with DHG
II To determine whether neoantigen-targeted ppDC facilitates systemic T cell-mediated adaptive immune activation in DHG patients
III To determine whether neoantigen-targeted ppDC facilitates a target-specific anti-tumor T cell expansion in DHG patients
IV To determine whether pro-inflammatory phenotypic changes in systemic immune cell populations are detected in peripheral blood in response to neoantigen-targeted ppDC vaccination in DHG patients
EXPLORATORY OBJECTIVES
I To estimate the potential efficacy of neoantigen-targeted ppDC in DHG patients
II To correlate physiologic and metabolic magnetic resonance imaging MRI with systemic immunologic response after neoantigen-targeted ppDC in DHG patients
III To isolate and sequence immunodominant anti-tumor T cell T-cell receptor TCRs stimulated by neoantigen-targeted ppDC in DHG patients
IV To explore whether study participants demonstrating immune-reactive responses to neoantigen-targeted ppDC harbor significantly different gastrointestinal microbiota profiles in comparison to unresponsive participants
OUTLINE
Patients undergo leukapheresis 10 days prior to first injection Patients then receive ppDC intradermally ID with poly ICLC intramuscularly IM in both arms every 2 weeks Q2W for total 3 doses and then every 6 months for up to 3 doses Patients undergo magnetic resonance imaging MRI throughout the trial Patients also undergo blood sample collection throughout the trial in addition to stool sample collection during screening and on the trial
After completion of study treatment patients are followed up at 30 and 120 days and then up to 24 months
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-00210 | REGISTRY | CTRP Clinical Trial Reporting Program | None |