Intratumoral DNX-2401 for High Grade Pediatric Brain Tumors

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Study ID
NCT07424092
Phase
PHASE2
Status
Recruiting
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Conditions

  • Embryonal Tumor of Brain
  • Ependymoma
  • High Grade Glioma
  • Pediatric
  • Recurrence
  • Refractory
  • Young Adult

Eligibility Criteria

Sex
ALL
Age
1 Year - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • DNX-2401 — BIOLOGICAL
    Single intratumoral infusion of 5 × 10\^10 viral particles of DNX-2401 after tumor biopsy.

Study Details

The goal of this clinical trial is to learn if intratumoral administration of DNX-2401 works to treat recurrent and refractory high grade brain tumors in children and young adults. It will also learn about the safety of DNX-2401. The main questions it aims to answer are: * Does a single intratumoral administration of DNX-2401 elicit tumor response and improve survival? * Is a single intratumoral administration of DNX-2401 safe and well tolerated? Participants will: * Undergo surgery for tumor biopsy followed by a single intratumoral administration of DNX-2401 * Visit the clinic periodically for checkups and tests

Key Dates

First listed
Feb 20, 2026
Start date
May 12, 2026
Status verified
May 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

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

Arms

  • Experimental: Single intratumoral infusion of DNX-2401
    Single intratumoral infusion of 5 × 10\^10 viral particles of DNX-2401 after tumor biopsy.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 52 weeks post-injection. ]

Central Contacts

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