CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 28 target
Drug / intervention
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)biological
Likely dose
Not stated in record
Key inclusion· 30
  • ✓Age ≥21 years (Stratum 1)
  • ✓Histopathologically proven newly-diagnosed de novo GBM, WHO Grade IV, MGMT low or unmethylated (Stratum 1)
  • ✓Age >3 and ≤25 years (Stratum 2)
  • ✓Histologically confirmed WHO Grade III or IV malignant glioma (Stratum 2)
Key exclusion· 36
  • ✕Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free ≥3 years (Stratum 1)
  • ✕MGMT methylated tumors (Stratum 1)
  • ✕Gliomatosis Cerebri (Stratum 1)
  • ✕Metastases below tentorium or beyond cranial vault; leptomeningeal involvement (Stratum 1)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04573140
NCT04573140Phase 1RecruitingOn Track
Long Recruiting
CompareCT.gov

A Phase I/II Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM), and Recurrent/Progressive Medulloblastoma (MB)

University of Florida·interventional·Posted Oct 5, 2020·Updated Jun 25, 2026

In Brief

A Phase 1 clinical trial evaluating 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) for Adult Glioblastoma and 2 related conditions. Currently recruiting, targeting 28 participants across 2 sites.

Detailed Summary

The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or unmethylated in adults only) and (Stratum 2) in pediatric patients with newly diagnosed HGG (pHGG). Funding Source - FDA OOPD

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Glioblastoma, High Grade Glioma, WHO Grade III or IV Malignant Glioma
CountriesUnited States
CollaboratorsPediatric Neuro-Oncology Consortium, University of California, San Francisco, CureSearch, Team Jack Foundation, Florida Department of Health, Food and Drug Administration (FDA)

Timeline

Phase 1Recruiting
202120222023202420252026202720282029
First PostedOct 5, 2020
Enrollment StartDec 13, 2021
Primary CompletionJul 1, 2027
Study CompletionJul 1, 2029
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 5.7 years agoPrimary completion in 12 months

Arms & Interventions

Adult GBM (Stratum 1)experimental

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)
Pediatric HGG (Stratum 2)experimental

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)

Interventions

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)biological

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.