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

NCT07143812 | Recruiting Phase 1

• 1 other identifier: MSC11FCD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Glioblastoma (GBM); Newly Diagnosed Glioblastoma Multiforme

Keywords

Glioblastoma; mesenchymal stem cell; gene therapy; suicide gene

Outcome Measures

Primary Outcomes (1)

• Number Of Adverse Events related to the treatment

  Evaluate the number of adverse event related to the treatment according to CTCAE V4.0 during the trial (including clinically significant changes in physical examination, radiographic images, safety lab tests, vital signs)

  Up to 12 months after treatment administration (Day 0)

Study Arms (1)

The investigational drug into the Intratumoral administration

OTHER

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

Drug: MSC11FCD

Interventions

MSC11FCD DRUG

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.

The investigational drug into the Intratumoral administration

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHA University: lead

Study Sites (1)

Bundang CHA Medical Center

Seongnam, Kyunggido, 13496, South Korea

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Jaejoon Lim, PhD

  CHA University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaejoon Lim, PhD

CONTACT

+82-31-780-5688; einses218@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 27, 2025
• Study Start: October 23, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)