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Stem cells armed with a virus take on deadly brain tumors

NCT ID NCT05139056

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

  • City of Hope Medical Center

    RECRUITING

    Duarte, California, 91010, United States

    Contact Email: •••••@•••••

  • Northwestern University

    SUSPENDED

    Chicago, Illinois, 60611, United States

  • Standford University

    RECRUITING

    Stanford, California, 94305, United States

    Contact Email: •••••@•••••

  • Wake Forest University

    NOT_YET_RECRUITING

    Winston-Salem, North Carolina, 27109, United States

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