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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07492316
Phase
PHASE1
Status
Recruiting
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Conditions

  • Recurrent Medulloblastoma

Eligibility Criteria

Sex
ALL
Age
4 Years - 39 Years
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 pediatric patients with recurrent/progressive Medulloblastoma (MB)

Key Dates

Start date
May 15, 2026
Status verified
Apr 2026
Primary completion
Sep 1, 2030
Completion
Mar 31, 2031

Study Design

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

Arms

  • Experimental: recurrent/progressive Medulloblastoma (rMB)

Primary Outcome Measure

Manufacturing feasibility [ Time Frame: from the date of surgery until administration of third vaccine, up to 15 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UF Health Shands Children's HospitalGainesvilleFlorida32608
Marcia Hodik, RN
[email protected]
352-273-9000
John Ligon, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UF Health Shands Children's Hospital· Gainesville, FL

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