RecruitingPhase 1NCT07143812

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


Sponsor

CHA University

Enrollment

10 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety of a novel stem cell-based gene therapy for patients who have just been diagnosed with glioblastoma (a serious brain tumor) and have already completed standard treatment. The therapy involves genetically engineered stem cells designed to target and kill remaining tumor cells. **You may be eligible if...** - You are between 19 and 70 years old - You have been newly diagnosed with glioblastoma confirmed by imaging - You have already received standard treatment and your expected survival is at least 3 months - You have not received any prior immunotherapy **You may NOT be eligible if...** - Your glioblastoma has returned (recurrent) - You have a pacemaker or other reason that prevents MRI scans - You received Gliadel wafer implants during surgery - You have serious organ dysfunction (liver, kidney, bone marrow, lungs, or heart) - You have another active cancer - You have uncontrolled blood pressure or serious infections - You have autoimmune diseases affecting the central nervous system (e.g., multiple sclerosis) - You have a known allergy to flucytosine or 5-fluorouracil Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMSC11FCD

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.


Locations(1)

Bundang CHA Medical Center

Seongnam, Kyunggido, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07143812


Related Trials