A Study to Evaluate the Safety of a Stem Cell-Based Gene and Cell Therapy in Patients With Newly Diagnosed Glioblastoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-70
SponsorCHA University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
MSC11FCD
DrugAdministration 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: The investigational drug into the Intratumoral administrationOther 1 intervention
Trial outcomes
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)
Time frame
Up to 12 months after treatment administration (Day 0)Sponsors and contacts
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Source ClinicalTrials.gov