drugset / Trial / NCT07143812

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

NCT07143812

Phase 1 Recruiting 10 enrolled CHA University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-10-23
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject MSC11FCD Cell therapy 1e+07 cells Other
Subject MSC11FCD Cell therapy 3e+07 cells Other

Indications