Stem cell–based gene and cell therapy for people with newly diagnosed glioblastoma.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 study administers MSC11FCD, an allogeneic bone marrow–derived mesenchymal stem cell product engineered to express a suicide gene, directly into the tumor cavity after surgical resection in adults with newly diagnosed glioblastoma. The trial uses escalating intratumoral doses to determine safety, tolerability, and the maximum tolerated dose, with close monitoring for adverse events and scheduled MRI assessments. Secondary endpoints will look for preliminary signs of anti-tumor activity and any impact on early recurrence. Eligible participants are adults aged 19–70 who can undergo surgery and attend follow-up visits at the study center.

Why it matters

Who can join: the full rules

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

Where it's running

• Bundang CHA Medical Center
  Seongnam, Kyunggido, South Korea Recruiting

Study contacts

• Principal investigator: Jaejoon Lim, PhD — CHA University
• Study coordinator: Jaejoon Lim, PhD
• Email: einses218@gmail.com
• Phone: +82-31-780-5688

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• G-CSF after chemo-radiation for MGMT-methylated glioblastoma

  This test checks whether giving G-CSF after standard chemo-radiation helps protect brain structure and thinking in adults with newly diagnosed MGMT-methylated glioblastoma.

  Recruiting Phase 2 Massachusetts General Hospital · Boston, Massachusetts · NCT06649851

• Brain connectome project in adults with brain glioma undergoing surgery

  This registry collects MRI data and clinical information from adults with glioma to see how brain networks relate to surgery and recovery.

  Recruiting Northwell Health · New York, New York · NCT07927595

• Targeted radioligand therapy for recurrent glioblastoma with Lu-177 XT771

  This early-phase study tests whether a radiolabeled medicine (Lu-177 XT771) delivered directly into the tumor cavity is safe and tolerable for adults with recurrent glioblastoma.

  Recruiting at 2 sites Early Phase 1 Beijing Tiantan Hospital · Beijing, Beijing Municipality and 1 other locations · NCT07648823

• Personalized Targeted Glioblastoma Therapies Guided by Ex Vivo Drug Screening

  This trial tests whether using a patient’s own tumor cells to screen drugs can guide a personalized treatment plan for people with newly diagnosed glioblastoma undergoing short-course radiotherapy.

  Recruiting Medical University of Vienna · Vienna, State of Vienna · NCT07627334

• LITT for ultra-early GBM recurrence within 1 week of pre-radiation planning

  This study tests whether a minimally invasive laser treatment can destroy an early GBM recurrence without delaying planned radiotherapy and chemotherapy.

  Recruiting Insel Gruppe AG, University Hospital Bern · Bern · NCT07616986

• Combined intracranial and intravenous NK cell therapy for malignant brain tumors

  This trial will test whether giving adults with recurrent malignant brain tumors their own expanded and activated natural killer (NK) cells into the tumor site and into the bloodstream is safe and feasible.

  Recruiting at 3 sites Peking University Third Hospital · Beijing, Beijing Municipality and 3 other locations · NCT07552233

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.