Glioblastoma Multiforme (GBM)
GBM has a devastating outcome. Where the median 5-year survival is around 5%, long-term responses are rare. The medical need for these patients is very high and improvements to the standard of care are critical. While anti-PD-1/PD-L1 checkpoint inhibitors have had striking success in other indications, GBM generally remains resistant to this approach. Additional study is needed to confirm any additional benefits.
Unfortunately, response rates to the checkpoint blockade in the treatment of GBM are very poor. About 5% of patients respond to this approach when used as a monotherapy.
GBM and CMV
Cytomegalovirus (CMV), a common virus which infects over 50% of adults by the age of 40, and Glioblastoma Multiforme (GBM) are purported to be associated. Although there is some debate with regard to both the presence and role that CMV plays in GBM, there are publications which support the association:
- Once, Twice, Three Times a Finding: Reproducibility of Dendritic Cell Vaccine Trials Targeting Cytomegalovirus in Glioblastoma
- Human cytomegalovirus infection and expression in human malignant glioma
- Sensitive detection of human cytomegalovirus in tumors and peripheral blood of patients diagnosed with glioblastoma
Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of ITI-1001 In Patients With Newly Diagnosed Glioblastoma (GBM)
The vaccine used in this clinical trial leverages ITI’s investigational ITI-1001 off-the-shelf cancer immunotherapy approach that leverages ITI’s proprietary UNITE® platform to target CMV-associated antigens (pp65, IE-1 & gB) in Newly-Diagnosed Glioblastoma Multiforme (GBM).
General Protocol
- Vaccine is comprised of 2 DNA plasmids: 1 plasmid encoding IE-1 and pp65 antigens as a fusion protein with LAMP1. Another plasmid encodes gB antigen as a fusion protein with LAMP1.
- DNA vaccine will be administered via IM injection with electroporation.
- 2 priming vaccinations given in the 4-6 weeks period between definitive surgical resection and initiation of SOC chemoradiation followed by 2 post-chemoradiation priming vaccinations (#3 and #4) and 5 ITI-1001 vaccine boosters given in parallel with maintenance TMZ as per Schedule of Assessments.
Official Title:
Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of ITI-1001 In Patients With Newly Diagnosed Glioblastoma (GBM)
Summary:
This Phase I clinical trial will evaluate the safety, tolerability, immunogenicity, and preliminary efficacy of 8 mg ITI-1001 in participants with newly diagnosed glioblastoma (GBM).
ClinicalTrials.gov Identifier: NCT05698199
More information about this trial can be found here.
Patient Resources
The patient resources section is intended to provide a list of brain tumor organizations and other information sources dedicated to brain tumor education, research and support.