Glioblastoma (GBM)Phase 1NCT07143812
A Study to Evaluate the Safety of a Stem Cell-Based Gene and Cell Therapy in Patients With Newly Diagnosed Glioblastoma
A Phase 1 study testing MSC11FCD in people with Glioblastoma (GBM) and Newly Diagnosed Glioblastoma Multiforme, run by CHA University at 1 site in South Korea.
Trial summary
This is a phase I clinical trial evaluating the safety, tolerability, and maximum tolerated dose of MSC11FCD, an investigational allogeneic bone marrow-derived mesenchymal stem cell therapy expressing a suicide gene, in patients with newly diagnosed glioblastoma. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Glioblastoma (GBM), Newly Diagnosed Glioblastoma Multiforme
- What is being tested?
- MSC11FCD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Oct 2025to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Bundang CHA Medical Center
Seongnam, Kyunggido, 13496
Jaejoon Lim, M.D., Ph.D, 82-31-780-5688, einses218@gmail.com
About this study
Official title: Clinical Research of Suicide Gene Expressing Allogenic Bone Marrow Derived Mesenchymal Stem Cells(MSC11FCD) in Patients With Newly Diagnosed Glioblastoma
This is a phase I clinical trial evaluating the safety, tolerability, and maximum tolerated dose of MSC11FCD, an investigational allogeneic bone marrow-derived mesenchymal stem cell therapy expressing a suicide gene, in patients with newly diagnosed glioblastoma. The investigational product is administered intratumorally following surgical resection. This study aims to explore whether MSC11FCD can provide a targeted, localized treatment option during the postsurgical period, potentially addressing residual tumor cells and reducing early recurrence.
Read the detailed description
Glioblastoma is a highly aggressive and rapidly progressing malignant brain tumor classified as a grade IV glioma. Despite the current standard of care, including surgical resection, radiation therapy, chemotherapy, and tumor treating fields, prognosis remains poor due to high recurrence rates, tumor heterogeneity, treatment resistance, and limited drug penetration across the blood-brain barrier. Moreover, glioblastoma often exhibits rapid tumor regrowth during the postsurgical recovery period when few therapeutic options are available.
This study investigates MSC11FCD, an investigational allogeneic bone marrow-derived mesenchymal stem cell product genetically modified to express a suicide gene. The product is administered intratumorally in newly diagnosed glioblastoma patients following surgical resection. The primary objective of the study is to evaluate the safety, tolerability, and maximum tolerated dose of MSC11FCD. Secondary objectives include the assessment of preliminary efficacy signals. The study aims to explore the potential of this novel therapeutic approach to selectively target residual tumor cells and potentially delay or prevent early recurrence, thereby contributing to improved patient outcomes and quality of life.
- Being tested
- MSC11FCD
- Keywords
- Glioblastoma, mesenchymal stem cell, gene therapy, suicide gene
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC11FCDDrug
Administration period: Single dose Route of administration: Intratumoral administration Dose: 1x10^7, 3x10^7cells/dose Summary: Administer the investigational drug in the amount of 1x10^7, 3x10^7cells per dose into the tumor or the tumor removal site using a syringe during surgery.
| Study group | Role | What they receive |
|---|---|---|
| The investigational drug into the Intratumoral administration | Other | The investigational drug in the amount of 1x10^7, 3x10^7cells per dose into the tumor or the tumor removal site using a syringe during surgery Receives: Drug: MSC11FCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Of Adverse Events related to the treatment
Evaluate the number of adverse event related to the treatment according to CTCAE V4.0 during the trial (including clinically significant changes in physical examination, radiographic images, safety lab tests, vital signs)
Measured: Up to 12 months after treatment administration (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start23 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaejoon Lim, PhD, Principal investigator, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143812
- Sponsor's protocol ID
- MSC11FCD
- Status last verified
- Jan 2026
- First submitted
- 4 Aug 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of Suicide Gene Expressing Allogenic Bone Marrow Derived Mesenchymal Stem Cells(MSC11FCD) in Patients With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT07143812
- Acronym / sponsor ID
- MSC11FCD
- Keywords
- Glioblastoma, mesenchymal stem cell, gene therapy, suicide gene
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I clinical trial evaluating the safety, tolerability, and maximum tolerated dose of MSC11FCD, an investigational allogeneic bone marrow-derived mesenchymal stem cell therapy expressing a suicide gene, in patients with newly diagnosed glioblastoma. The investigational product is administered intratumorally following surgical resection. This study aims to explore whether MSC11FCD can provide a targeted, localized treatment option during the postsurgical period, potentially addressing residual tumor cells and reducing early recurrence.
Detailed description
Glioblastoma is a highly aggressive and rapidly progressing malignant brain tumor classified as a grade IV glioma. Despite the current standard of care, including surgical resection, radiation therapy, chemotherapy, and tumor treating fields, prognosis remains poor due to high recurrence rates, tumor heterogeneity, treatment resistance, and limited drug penetration across the blood-brain barrier. Moreover, glioblastoma often exhibits rapid tumor regrowth during the postsurgical recovery period when few therapeutic options are available.
This study investigates MSC11FCD, an investigational allogeneic bone marrow-derived mesenchymal stem cell product genetically modified to express a suicide gene. The product is administered intratumorally in newly diagnosed glioblastoma patients following surgical resection. The primary objective of the study is to evaluate the safety, tolerability, and maximum tolerated dose of MSC11FCD. Secondary objectives include the assessment of preliminary efficacy signals. The study aims to explore the potential of this novel therapeutic approach to selectively target residual tumor cells and potentially delay or prevent early recurrence, thereby contributing to improved patient outcomes and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The investigational drug into the Intratumoral administration | Other | Drug: MSC11FCDThe investigational drug in the amount of 1x10^7, 3x10^7cells per dose into the tumor or the tumor removal site using a syringe during surgery |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSC11FCDAdministration period: Single dose Route of administration: Intratumoral administration Dose: 1x10^7, 3x10^7cells/dose Summary: Administer the investigational drug in the amount of 1x10^7, 3x10^7cells per dose into the tumor or the tumor removal site using a syringe during surgery. | Drug | The investigational drug into the Intratumoral administration |
Primary outcome
Number Of Adverse Events related to the treatment
Time frame: Up to 12 months after treatment administration (Day 0)
Evaluate the number of adverse event related to the treatment according to CTCAE V4.0 during the trial (including clinically significant changes in physical examination, radiographic images, safety lab tests, vital signs)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaejoon Lim, PhD principal investigator
CHA University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSC11FCD in people with Glioblastoma (GBM) and Newly Diagnosed Glioblastoma Multiforme, run by CHA University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaejoon Lim, PhD (+82-31-780-5688, einses218@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Of Adverse Events related to the treatment (time frame: Up to 12 months after treatment administration (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.