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

NCT03988283 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

  • Pediatric Recurrent Central Nervous System Tumors

Interventions

BIOLOGICAL

Personalized neoantigen DNA vaccine

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

DEVICE

Papivax Biotech TDS-IM v2.0

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

PROCEDURE

Peripheral blood draw

-After trial enrollment and up to 7 days after the first vaccine dose (baseline); no more than 2 weeks after the 3rd vaccine dose; no more than 2 weeks after the 6th vaccine dose; two weeks after the last dose; time of progression or discontinuation (optional)

Sponsors & Collaborators

  • Children's Discovery Institute

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Michael A Huang, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-02
Primary Completion
2029-03-31
Completion
2031-02-28
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03988283 on ClinicalTrials.gov