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

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

This trial will test whether an injected stem cell therapy carrying a suicide gene is safe for adults with newly diagnosed glioblastoma after surgery.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 19 Years to 70 Years
• Sex: All
• Sponsor: CHA University (other)
• Drugs / interventions: immunotherapy, chemotherapy, radiation
• Locations: 1 site (Seongnam, Kyunggido)
• Trial ID: NCT07143812 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 19–70 with newly diagnosed glioblastoma who have undergone surgical resection, have an expected survival of at least three months, and have not received prior immunotherapy.

Not a fit: Patients with recurrent glioblastoma, known DPD deficiency, contraindications to contrast MRI, prior Gliadel wafer implantation, or severe major-organ dysfunction are unlikely to be eligible or to benefit from this treatment.

Why it matters

Potential benefit: If successful, the therapy could selectively kill residual tumor cells at the resection site and reduce early recurrence, potentially prolonging progression-free survival.

How similar studies have performed: Local gene- and cell-based suicide-gene strategies have shown promising preclinical results and limited early-phase clinical signals, but broad clinical benefit in glioblastoma has not yet been established.

Eligibility criteria

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 this trial is running

Seongnam, Kyunggido

• Bundang CHA Medical Center — Seongnam, Kyunggido, South Korea (RECRUITING)

Study contacts

• Principal investigator: Jaejoon Lim, PhD — CHA University
• Study coordinator: Jaejoon Lim, PhD

Conditions: Glioblastoma, Newly Diagnosed Glioblastoma Multiforme, mesenchymal stem cell, gene therapy, suicide gene