Suicide gene stem cells take aim at glioblastoma
NCT ID NCT07143812
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new treatment called MSC11FCD for people with newly diagnosed glioblastoma, an aggressive brain cancer. The treatment uses donor stem cells that carry a 'suicide gene' and are injected into the brain during surgery to kill any remaining cancer cells. The study will enroll 10 patients to check if the treatment is safe and to find the best dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MSC11FCD (stem cells with a suicide gene)
- What this could lead to
- If it works, this could point toward a new way to kill leftover tumor cells after surgery and delay glioblastoma recurrence.
- What could go wrong
- This is a very early, small Phase 1 trial focused on safety, not effectiveness. The approach may not work in humans, and there are risks from the surgery and the stem cells themselves.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2026
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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19 to 70 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients aged 19 to 70 * Patients diagnosed with newly diagnosed glioblastoma based on medical imaging after receiving standard therapy for glioblastoma * Patients whose expected survival period is at least 3 months * Patients who have not received any other types of immunotherapy * Patients who have been given a sufficient explanation of the purpose and details of the clinical trial and the characteristics of the investigational drug from an investigator and who signed the consent form or had a legal guardian or representative sign the consent form prior to the beginning of this clinical trial Exclusion Criteria: * Patients with recurrent glioblastoma. Known Dihydropyrimidine Dehydrogenase (DPD) deficiency Contraindications to contrast-enhanced MRI (e.g., patients with pacemakers or other reasons preventing MRI scans according to the study schedule) * Patients who received Gliadel wafer implantation during surgery * Patients with severe dysfunction of major organs (liver, kidney, bone marrow, lung, heart) as determined by the investigator * Patients with concurrent malignancies other than glioblastoma or a history of malignancy within the past 5 years * Patients with uncontrolled hypotension or hypertension * Patients with serious infections as determined by the investigator, including sepsis, hepatitis A, B, or C * Patients with a Karnofsky Performance Scale (KPS) score \< 50 * Patients with autoimmune diseases involving the central nervous system (e.g., multiple sclerosis, myasthenia gravis, acute disseminated encephalomyelitis) * Patients with a history of allergy to flucytosine (5-FC), its excipients, or 5-fluorouracil (5-FU) * Pregnant or breastfeeding women, patients planning to become pregnant during the study period, or those unwilling to use appropriate contraception * Participation in another clinical trial within 30 days prior to enrollment * Any condition that, in the opinion of the investigator, would make the patient unsuitable for study participation
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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
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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Bundang CHA Medical Center
RECRUITINGSeongnam, Kyunggido, 13496, South Korea
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