RecruitingPhase 1NCT07492316

RNA-lipid Particle (RNA-LP) Vaccines for Recurrent/Progressive Medulloblastoma (MB)

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)

Sponsor

University of Florida

Enrollment

24 participants

Start Date

Apr 24, 2026

Study Type

INTERVENTIONAL

Conditions

Recurrent Medulloblastoma

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 pediatric patients with recurrent/progressive Medulloblastoma (MB)

Eligibility

Min Age: 4 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called 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 people with recurrent medulloblastoma. The study is currently recruiting participants at 1 location. People eligible for this study include aged 4 Years to 39 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous 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.

Locations(1)

UF Health Shands Children's Hospital

Gainesville, Florida, United States

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NCT07492316

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