A Study to Evaluate the Safety of a Stem Cell-Based Gene and Cell Therapy in Patients With Newly Diagnosed Glioblastoma

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. 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.

Eligibility

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

Conditions3

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