A Phase 1 interventional study of Personalized cellular vaccine in Glioblastoma, sponsored by Guangdong 999 Brain Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by Guangdong 999 Brain Hospital · Phase 1, Interventional, and Treatment
The treatment option for recurrent glioblastoma is limited. Immune cell based therapy for glioblastoma has shown some efficacy. This study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with recurrent glioblastoma and then immunizing the patients with personalized antigen pulsed DCs. Immune responses to the immunized antigens will be monitored. Safety and efficacy will be observed in this study.
This is an open label, single-arm, single-institution, Phase I study designed to investigate the safety and efficacy of personalized cellular vaccines for patients with recurrent glioblastoma (GBM). Recurrent GBM patients will undergo tumor resection. The tumors will be analyzed for the expression of a panel of glioma-associated antigens and immune-related genes. Patients will undergo leukapheresis to collect mononuclear cells for DC generation. Based on the expression profiles of tumor-associated antigens, in vitro transcribed mRNA will be generated to pulse autologous DCs. Patients will be conditioned with immune adjuvants before and during immunization. Patients will receive biweekly vaccines. The antitumor specific T cell responses will be measured. Safety and efficacy will be monitored. The objective is to assess the safety of the personalized cellular vaccines and T cell responses. The efficacy of the vaccines will be evaluated using iRANO criteria, progression-free survival and overall survival.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 10 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Guangdong 999 Brain Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will undergo tumor resection. They will receive biweekly cellular vaccines consisting of mRNA tumor antigen pulsed autologous DCs.
Biological: Personalized cellular vaccine
Patients with recurrent glioblastoma will undergo tumor resection and receive tumor antigen pulsed cellular vaccines.
Also known as: Tumor antigen pulsed DC autologous cellular vaccine
Incidence of treatment-emergent adverse events and severe adverse events (safety and tolerability)
Incidence of adverse events and severe adverse events to measure safety and tolerability of mRNA-TAA pulsed autologous DC, allogeneic PBMCs and autologous tumor cellular vaccines.
Time frame: 3 years since the beginning of the first vaccine
Antitumor antigen specific T cell response
The frequency of the peripheral CD8+ and CD4+ T cell response to the vaccine will be measured.
Time frame: 4 weeks after the last vaccine
Progression-free survival
Progression-free survival will be monitored for 1 year.
Time frame: 12 months since the beginning of the first vaccine
Overall survival
Overall survival will be monitored for 3 years.
Time frame: 3 years since the beginning of the first vaccine
Plan to share: Undecided
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Guangdong 999 Brain Hospital