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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT04573140
Phase
PHASE1
Status
Recruiting
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Conditions

  • Adult Glioblastoma
  • High Grade Glioma
  • WHO Grade III or IV Malignant Glioma

Eligibility Criteria

Sex
ALL
Age
4 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Dec 13, 2021
Status verified
Apr 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2029

Study Design

Enrollment
28 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adult GBM (Stratum 1)
  • Experimental: Pediatric HGG (Stratum 2)

Primary Outcome Measure

Manufacturing feasibility [ Time Frame: from the date of surgery until adminstration of third vaccine, up to 20 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UF HealthGainesvilleFlorida32610
Marcia Hodik, RN
[email protected]
352-273-6971
Ashley Ghiaseddin, MD (PRINCIPAL_INVESTIGATOR)
John Ligon, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By research site
UF Health· Gainesville, FL

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