Stem cells armed with a virus take on deadly brain tumors
NCT ID NCT05139056
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times
Summary
This early-stage trial tests a new treatment for people with glioblastoma, an aggressive brain cancer that has come back. The therapy uses special neural stem cells that can find cancer cells in the brain and release a virus that kills them. The main goal is to check the safety of giving multiple doses directly into the brain, and to see if it helps control the disease.
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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 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Aug 2027
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: * Patient must be age \>= 18 years * Patient has a Karnofsky performance status of \>= 70% * Patient has a life expectancy of \>= 3 months * When determining the maximum tolerated number of treatment cycles (MTC): patient has a histologically confirmed diagnosis of a grade 3 or 4 glioma (eg., glioblastoma, grade 4 astrocytoma, grade 3 astrocytoma, grade 3 oligodendroglioma). (This part of the study has been completed). * When enrolling to Treatment Schedules 4 and 4a: patient has glioblastoma at first recurrence. * Imaging studies show evidence of recurrent, supratentorial tumor(s). * Patient's high-grade glioma has recurred or progressed after prior treatment with brain radiation and temozolomide * The patient must be in need of surgery for tumor resection * Based on the neurosurgeon's judgment, there is no anticipated physical connection between the post-resection tumor cavity and the cerebral ventricles * Absolute neutrophil count (ANC) of \>= 1000 cells/mm\^3 * Platelet count \>= 100,000 cells/mm\^3 * Total bilirubin =\< 2.0 mg/dl * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 4 times the institutional upper limit of normal * Serum creatinine =\< the institutional upper limit of normal * At least 2 weeks from taking the last dose of a targeted agent * At least 4 weeks from the last dose of bevacizumab For temozolomide, an interval of 23 days is required from the last dose administered if the patient was recently treated with adjuvant temozolomide, consisting of temozolomide daily for 5 days, repeated every 28 days. * At least 2 weeks from taking the last dose of a targeted agent. * At least 4 weeks from the last dose of bevacizumab. * All significant toxicities from previous anticancer therapy must have stabilized to a new baseline or resolved. * All participants must have the ability to understand and the willingness to sign a written informed consent. * The effects of this treatment on a developing fetus are unknown. Therefore, female patients of childbearing potential and sexually-active male patients or who are able to impregnate their partner, must agree to use an effective method of contraception while participating in this study. Patients of childbearing potential must have a negative pregnancy test =\< 2 week prior to registration. Exclusion Criteria: * Patient has multi-focal disease. * Patient is receiving radiation, chemotherapy, or another investigational agent. * Patient has had prior therapy with neural stem cells. * Patient has not recovered from any toxicity (\> grade 1) of prior therapies, except alopecia. * Patient is unable to undergo a brain MRI. * Patient has chronic or active viral infections of the central nervous system (CNS). * Patient has a coagulopathy or bleeding disorder. * Patient has an uncontrolled illness including ongoing or active infection. * Patient has another active malignancy. * Patient is pregnant or breastfeeding. * A patient has a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the safety monitoring requirements and completion of treatment according to this protocol.
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Genom att skicka in godkänner du våra Användarvillkor
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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
4 sites. 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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
Contact Email: •••••@•••••
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Northwestern University
SUSPENDEDChicago, Illinois, 60611, United States
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Standford University
RECRUITINGStanford, California, 94305, United States
Contact Email: •••••@•••••
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Wake Forest University
NOT_YET_RECRUITINGWinston-Salem, North Carolina, 27109, United States
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