Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

June 26, 2010

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2024

Conditions
Glioblastoma
Interventions
BIOLOGICAL

Dendritic Cells Vaccine

"Right after the surgical resection of the tumor, leukapheresis will be performed.~At least 5x109 PBMC must be collected by leukapheresis, so as to make the whole immunotherapy schedule workable.~Immunotherapy will follow radiochemotherapy and will comprise 4 vaccinations every second week (injections I, II, III, IV), 2 further monthly vaccinations (injections V, VI) and a final vaccination (injection VII) 2 months after the sixth one. Injections I, V, VI and VII will contain 10 million tumor lysate-loaded DC, while the others will be of 5 million cells only. In correspondence to the third vaccine injection (week 13), mTMZ will start.~Vaccine doses will be injected in the forearm of the patient."

Trial Locations (1)

20133

RECRUITING

UOC Neuro-oncologia Molecolare, Milan

All Listed Sponsors
lead

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

OTHER

NCT04801147 - Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme | Biotech Hunter | Biotech Hunter