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Recruiting Phase 1 NCT03988283

Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Central Nervous System Tumors

Trial Parameters

Condition Pediatric Recurrent Central Nervous System Tumors
Sponsor Washington University School of Medicine
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 7
Sex ALL
Min Age N/A
Max Age 25 Years
Start Date 2024-10-02
Completion 2029-03-31
Interventions
Personalized neoantigen DNA vaccinePapivax Biotech TDS-IM v2.0Peripheral blood draw

Brief Summary

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.

Eligibility Criteria

Step 1 Eligibility Criteria for Tissue Sequencing Inclusion Criteria: * Any patient between the ages of 12 and 25 years of age (inclusive) who was diagnosed with a pediatric CNS (brain or spine) of any histologic subtype, who has now developed recurrent or refractory disease. * All patients enrolled in this trial will receive treatment for recurrent and/or refractory pediatric CNS tumors, including systemic agents, investigational agents, or radiation therapy, prior to receiving the neoantigen DNA vaccine. Co-enrollment to another interventional clinical trial is permitted during the vaccine manufacture period. * Availability of tissue collected after progression for sequencing to determine presence of targetable neoantigen. This may be fresh tissue collected as part of routine care, another research project or banked fresh frozen samples from tissue obtained at the time of progression from a biopsy, subtotal resection, total gross resection, or re-resection. * Life expectancy \> 24 we

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