Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

June 24, 2020

Primary Completion Date

December 22, 2022

Study Completion Date

December 22, 2022

Conditions
GlioblastomaAdult GliosarcomaNeoplasms, BrainNeoplasms, Germ Cell and EmbryonalRecurrent Glioblastoma
Interventions
DRUG

MSC11FCD

"Administration period: Single dose Route of administration: Intratumoral administration Dose: 1x10\^7, 3x10\^7cells/dose Summary: Administer the investigational drug in the amount of 1x107, 3x107cells per dose into the tumor or the tumor removal site using a syringe during surgery.~Concomitant drug: 5-Flucytosine (prodrug) Dose: 150mg/kg/day~Directions:~Administration period and directions: Administer 150m of 5-Flucytosine per kilogram of body weight every 6 hours for a total of 4 times a day (QID) for a duration of 7 days after surgery.~Route of administration: Oral administration"

Trial Locations (1)

13496

Bundang CHA Medical Center, Seongnam

All Listed Sponsors
collaborator

Ajou University School of Medicine

OTHER

lead

CHA University

OTHER

NCT04657315 - Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients | Biotech Hunter | Biotech Hunter