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Personalized neoantigen DNA vaccine

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

  • RegistryNCT03988283
  • PhasePhase 1
  • StatusRecruiting
  • ConditionPediatric Recurrent Central Nervous System Tumors
  • SponsorWashington University School of Medicine
How Personalized neoantigen DNA vaccine works1 min

The drug

What is being tested.

At each vaccination time point, patients will receive one injection of the neoantigen DNA vaccine, one injection into the vastus lateralis.

All study injections will be given intramuscularly using an integrated electroporation device (TDS-IM v2.0 device - Papivax Biotech).

The study

How the trial runs.

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.

Live record on ClinicalTrials.gov →

Eligibility

Who the study is looking for.

  • Step 1 Eligibility Criteria for Tissue Sequencing
  • Any patient between the ages of 12 and 25 years of age (inclusive) who was diagnosed with any of the following:
  • High-grade glioma (HGG); newly diagnosed patients
  • Diffuse midline glioma (DMG); newly diagnosed patients
  • A pediatric CNS (brain or spine) tumor of any histologic subtype, who has now developed recurrent or refractory disease.
  • All patients enrolled in this trial will receive treatment for 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.

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.

How these trials work: what Phase 1 actually is · common questions Not clinical evidence.

Not sure whether you would qualify?

Would this trial apply to me?