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RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM)

NCT06389591 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-15

No results posted yet for this study

Summary

This is a Phase I study to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in adult patients with recurrent glioblastoma.

Conditions

Interventions

BIOLOGICAL

pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1)

pp65 RNA loaded lipid particles or pp65 RNA-LPs administered intravenously

BIOLOGICAL

RNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2)

personalized tumor mRNA, pp65 fl LAMP mRNA and DOTAP liposomes or RNA loaded lipid particles, RNA-LPs administered intravenously

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Ashley Ghiaseddin, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-02
Primary Completion
2026-12-01
Completion
2027-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06389591 on ClinicalTrials.gov