Stem cell virus therapy takes on deadly brain tumors
NCT ID NCT06169280
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This early-phase study tests whether giving multiple doses of a special virus carried by neural stem cells is safe and possible for people with newly diagnosed high-grade glioma. Participants receive the therapy directly into the brain before, during, and after standard radiation and chemotherapy. The study involves 20 adults and focuses on safety, tumor response, survival, and quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2030
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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18 years and older
- 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: * Diagnosis of a high-grade glioma (WHO grade 3 or grade 4). * Patients must have presumed high grade glioma (WHO grade 3 or 4) based on clinical and radiologic evaluation for registration. * A pathologic confirmation of high grade glioma must be made at the time of stereotactic biopsy prior to NSC-CRAd-S-pk7 injection; if this is not possible, the injection will not be performed and the subject will no longer be eligible for the study). * Tumor must be accessible for injection and must not be located in the brainstem or contained within the ventricular system. * Planning to undergo standard radiation/chemotherapy. * 18 years of age or older. * Performance status (PS) must be WHO PS of \< 2. * Stable or decreasing dose of corticosteroids equivalent to ≤ 6 mg/day for the 5 days prior to inclusion * Serum glutamic-oxaloacetic transaminase (SGOT or AST) \< 3x upper limit of normal * Serum creatinine \< 2mg/dl * Platelets \> 100,000/mm3 and white blood cells (WBCs) \> 3000/mm3 Exclusion Criteria: * Prior or ongoing liver disease including known cirrhosis. * Known hepatitis B or C infection, known HIV infection. * Chronic use of immunosuppressive drugs (with exception of corticosteroids required for mass effect). * Acute viral, bacterial or fungal infections requiring therapy. * Pregnant or breast-feeding patients. * Evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers). * Prior radiation therapy to the brain or prior treatment for brain tumor.
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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
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Northwestern University
Chicago, Illinois, 60611, United States
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Other studies related to the condition(s) this trial covers.
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