Brain tumor virus therapy tested in kids and young adults
NCT ID NCT07424092
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether a single injection of DNX-2401, a virus designed to kill cancer cells, can shrink or stabilize recurrent high-grade brain tumors in 39 children and young adults. Participants receive the virus directly into the tumor during a biopsy procedure. The study aims to see if the treatment improves survival and is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DNX-2401 (a virus that infects and kills cancer cells)
- What this could lead to
- If it works, this could offer a new treatment option for children and young adults with hard-to-treat brain tumors that have come back.
- What could go wrong
- This is a small, early-phase trial (39 people) with no control group, so results may not apply widely. The virus is injected directly into the brain, which carries risks like swelling or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The participant or participant's parents or legally acceptable representatives (if applicable) provides written informed consent for the trial and the pediatric participant provides writ-ten assent, where applicable, based on age and country requirements. * Patients with recurrent or refractory high grade malignant brain tumors (high grade glioma, embryonal CNS tumors \[medulloblastomas, ATRT, EMTR, pineoblastoma\], and ependymomas) diagnosis based on initial histopathological diagnosis and further clinical and radiological fol-low-up, in whom gross total resection is not feasible, and with a life expectancy of at least 16 weeks at the time of consent. * Recurrences within the radiation field will be considered if there is confirmed growth of the lesion in two consecutive MRI or if they occur at least 12 weeks after completion of ra-diation therapy, or if there is clear histopathological confirmation of tumor recurrence. * Male and female participants age ≥ 1 years and ≤ 25 years. * A single measurable lesion longer than 10 mm in two perpendicular diameters, considered by the investigator to be accessible for safe stereotactic biopsy and virus injection. * Lansky Performance Status (LPS) ≥ 60 for participants \< 16 years, or Karnofsky Performance Status (KPS) ≥ 60 for participants ≥ 16 years. * No other chemotherapy or immunotherapy in the 4 weeks before inclusion. * Steroids: free off or requiring decreasing or stable corticosteroid dose (≥ 0.05 mg/kg dexa-methasone daily, or equivalent for other steroids) in the 2 weeks before DNX-2401 admin-istration. * Radiation: no craniospinal irradiation, total body irradiation nor focal irradiation in the 6 weeks before inclusion. * Autologous Stem Cell Transplantation: patients must be ≥ 3 months post-transplant prior to entry of the study. * Patients must be fully recovered from all acute treatment related toxicities of all prior therapies. * Laboratory test: adequate hematological (platelets ≥ 100x10e9/L, neutrophils ≥ 1.0x10e9/L, hemoglobin ≥ 5,6 mmol/L), renal function (creatinine \<1.5 times ULN) and liver function (≤3 times ULN) values. * Negative pregnancy test for female participants of child-bearing potential, where child-bearing potential is defined as a fertile female who is pubertal or post-pubertal and not permanently sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy). * Female participants of child-bearing potential, who are sexually active, agree to use ac-ceptable birth control starting at informed consent and continuing for at least 120 days af-ter DNX-2401 administration. Male participants agree to use acceptable birth control start-ing at informed consent and continuing for at least 90 days after DNX-2401 administration. Exclusion Criteria: * Any medical or psychological condition or disease that might interfere with the subject's ability to participate or give informed consent (if older than 16 years). * Spinal location, or lesions considered risky for stereotactic injection of virus or that might favor entrance of the virus in the ventricular system. * Any treatment outside the allowable guidelines outlined in the inclusion criteria. * Severe acute infection or intercurrent medical condition including, but not limited to se-vere renal, hepatic, heart or bone marrow failure that based on investigator discretion do not permit inclusion in the study. * Subjects with immunodeficiency or autoimmune conditions, active hepatitis or known HIV. No testing for Hepatitis B, Hepatitis C and HIV is required unless mandated by local health authority. * Subjects with another primary malignancy. * Prior history of encephalitis, multiple sclerosis or other CNS infections or primary CNS dis-ease that would interfere with evaluation. * Li Fraumeni Syndrome or a known germ line deficit in the retinoblastoma gene or its relat-ed pathways. * Concurrent therapy with any antiviral drug or any immunosuppressive drug (except ster-oids). * Life or life-attenuated vaccinations within 30 days prior to DNX-2401 administration and while participating in the study. Killed vaccines are permitted. * Prior participant in experimental viral therapy. * Inability to undergo MRI scans for any reason. * Pregnancy or breastfeeding.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Center Clínica Universidad de Navarra
RECRUITINGPamplona, Navarre, 31008, Spain
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Princess Máxima Centrum
NOT_YET_RECRUITINGUtrecht, 3584, Netherlands
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