NCT04573140View on ClinicalTrials.gov

A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)

PHASE1RecruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

December 13, 2021

Primary Completion Date

July 1, 2027

Study Completion Date

July 1, 2029

Conditions
Adult GlioblastomaHigh Grade GliomaWHO Grade III or IV Malignant Glioma
Interventions
BIOLOGICAL

Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs)

RNA-LP vaccines will be administered intravenous. Three RNA-LP vaccines will be administered every 2 weeks followed by 12 cycles of adjuvant monthly RNA-LP vaccines for a total of 15 vaccines.

Trial Locations (1)

32610

RECRUITING

UF Health, Gainesville

Sponsors

Collaborators (1)

CureSearch
All Listed Sponsors
collaborator

Pediatric Neuro-Oncology Consortium

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

CureSearch

UNKNOWN

collaborator

Team Jack Foundation

UNKNOWN

collaborator

Florida Department of Health

OTHER_GOV

collaborator

Food and Drug Administration (FDA)

FED

lead

University of Florida

OTHER