Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC) (PERCELLVAC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02709616|
Recruitment Status : Active, not recruiting
First Posted : March 16, 2016
Last Update Posted : June 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Biological: Personalized cellular vaccine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Personalized Cellular Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma (PerCellVac)|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Personalized cellular vaccine
DC based cellular vaccine
Biological: Personalized cellular vaccine
Biological: DC-based cellular vaccine. Subjects will undergo surgical resection and standard 6-week chemo/radiotherapy and cycles of TMZ treatment. They will receive biweekly cellular vaccines.
Other Name: Tumor antigen pulsed DC vaccine
- Incidence of treatment-emergent adverse events and severe adverse events [safety and Tolerability] [ Time Frame: 3 years since the beginning of the first vaccine ]Incidence of adverse events and severe adverse events to measure safety and tolerability of mRNA-TAA pulsed autologous DC cellular vaccine
- Antitumor antigen specific T cell response [ Time Frame: 4 weeks after the last vaccine ]The frequency of peripheral CD8+ and CD4+ T cell response to the vaccine.
- Progression-free survival [ Time Frame: 12 months since the beginning of the first vaccine. ]Progression-free survival will be monitored for 1year.
- Overall survival [ Time Frame: 3 years since the beginning of the first vaccine ]Overall survival will be monitored for 3 years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709616
|Guangdong 999 Brain Hospital|
|Guangzhou, Guangdong, China|
|Principal Investigator:||Jian Zhang, M.D.||Guangdong 999 Brain Hospital|