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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06389591
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1) — BIOLOGICAL
    pp65 RNA loaded lipid particles or pp65 RNA-LPs administered intravenously
  • RNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2) — BIOLOGICAL
    personalized tumor mRNA, pp65 fl LAMP mRNA and DOTAP liposomes or RNA loaded lipid particles, RNA-LPs administered intravenously

Study Details

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.

Key Dates

Start date
Dec 2, 2024
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: pp65 RNA-LPs (DP1) before biopsy
    Participants will receive pp65 RNA-LPs (DP1) starting before tumor biopsy/resection. All patients will receive three pp65 RNA-LP vaccines (DP1) before receiving full dose monthly RNA-LPs (RNA loaded lipid particles, RNA-LPs, DP2).

Primary Outcome Measure

Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines [ Time Frame: from the date of surgery until administration of third vaccine, up to 20 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UF HealthGainesvilleFlorida32608
Phuong Deleyrolle
[email protected]
352-273-5519
Ashley Ghiaseddin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
UF Health· Gainesville, FL

Related Studies