Status:
NOT_YET_RECRUITING
A Study to Evaluate the Safety of a Stem Cell-Based Gene and Cell Therapy in Patients With Newly Diagnosed Glioblastoma
Lead Sponsor:
CHA University
Conditions:
Glioblastoma (GBM)
Newly Diagnosed Glioblastoma Multiforme
Eligibility:
All Genders
19-70 years
Phase:
PHASE1
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07143812
Start Date
September 1 2025
End Date
December 31 2026
Last Update
August 27 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.