Actively Recruiting
Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Central Nervous System Tumors
Led by Washington University School of Medicine · Updated on 2026-05-07
7
Participants Needed
1
Research Sites
334 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
C
Children's Discovery Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this research study is to learn about the safety and feasibility of giving a personalized DNA vaccine to people with central nervous system tumors that have returned or have been resistant to treatment.
CONDITIONS
Official Title
Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Central Nervous System Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 25 years inclusive
- Diagnosed with high-grade glioma (HGG), diffuse midline glioma (DMG), or any pediatric CNS tumor with recurrent or refractory disease
- Prior treatment for pediatric CNS tumor including systemic, investigational agents, or radiation therapy
- Availability of tissue for sequencing to identify targetable neoantigen
- Life expectancy greater than 24 weeks
- Ability to understand and sign informed consent or have a guardian who can
- Women of childbearing potential and men must agree to use effective contraception
- Personalized neoantigen DNA vaccine manufactured for administration
- HGG or DMG patients must have recurrent or refractory disease after at least one prior treatment
- Karnofsky/Lansky performance status 50% or higher
- Life expectancy greater than 12 weeks
- Required washout periods from prior therapies before first vaccine dose
- Adequate bone marrow and organ function as defined by specific blood counts and lab values
- Any prior adverse events resolved to grade 1 or less
- Minimal systemic corticosteroid use allowed on vaccine day
- Bevacizumab allowed for edema control
You will not qualify if you...
- History of other malignancy within 3 years except certain cured or early-stage cancers
- Known allergy or serious reaction to vaccines
- Uncontrolled illnesses like heart failure, unstable angina, arrhythmia, or psychiatric conditions limiting compliance
- Immunodeficiency or autoimmune conditions requiring immunosuppressive therapy
- HIV with CD4 counts below 350 or recent AIDS-defining infection
- Increased intracranial pressure, hemorrhage, uncontrolled seizures, or need for immediate palliative care
- Thigh circumference less than 35 cm or skinfold thickness at injection site over 50 mm
- Physical conditions obscuring injection site assessment or permanent body art interfering with procedure
- Metal implants or electronic devices near injection area
- Significant hematologic, pulmonary, cardiovascular, hepatic, or renal abnormalities
- Seizure disorder must be well-controlled; neurologic deficits stable for at least 1 week
- No candidate neoantigen identified
- Active infection requiring systemic therapy or fever above 38.1°C within 7 days before first vaccine dose
- Live vaccine administration within 30 days before first vaccine dose (except COVID-19 vaccine)
- Pregnant or breastfeeding; women must have negative pregnancy test within 7 days before vaccination
- History of syncope within 12 months before first vaccine dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
M
Michael A Huang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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