NCT07143812

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

Clinical Research of Suicide Gene Expressing Allogenic Bone Marrow Derived Mesenchymal Stem Cells(MSC11FCD) in Patients With Newly Diagnosed Glioblastoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: CHA University · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Glioblastoma (GBM)
• Newly Diagnosed Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	MSC11FCD	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.

Timeline

• Start date: 2025-10-23
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-08-27
• Last updated: 2026-01-22

Locations

1 site across 1 country: South Korea