Personalized DNA Vaccine for Glioblastoma

Recruiting in Palo Alto (17 mi)

Overseen ByTanner M Johanns, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?This trial is testing a custom-made vaccine designed to help the immune system attack brain cancer cells. It targets patients with a specific type of brain cancer that hasn't responded to usual treatments. The vaccine works by teaching the immune system to recognize and destroy cancer cells based on unique markers.

Eligibility Criteria

This trial is for adults with newly diagnosed, unmethylated glioblastoma who've had a craniotomy or resection. Participants must consent to genome sequencing and agree to use contraception. They should have normal organ function, not be on high-dose steroids, and can't have other cancers within the last 3 years or any immune system disorders.

Participant Groups

The study tests a personalized neoantigen-based DNA vaccine using the CELLECTRA®2000 EP Device in patients with glioblastoma. It aims to assess safety and how well it triggers an immune response against the cancer.

1Treatment groups

Experimental Treatment

Group I: Vaccine (GNOS-PV01 + INO-9012)Experimental Treatment3 Interventions

* Standard radiation therapy will be administered per standard of care and is outside the scope of this study. * GNOS-PV01 + INO-9012 will be given on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle beginning with Cycle 2.

Personalized neoantigen DNA vaccine is already approved in United States for the following indications:

🇺🇸 Approved in United States as GNOS-PV02 for: