← Back to Search

Cancer Vaccine

Personalized DNA Vaccine for Glioblastoma

Phase 1

Waitlist Available

Led By Tanner M Johanns, M.D., Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing a new vaccine for brain cancer that is tailored to each patient's individual tumor. The goal is to see if the vaccine is safe and works well.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site, allergic responses similar to those from other vaccines (like hives or difficulty breathing), and possibly effects related to IL-12 like fatigue or flu-like symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of generating a personalized neoantigen DNA vaccine for patients with newly diagnosed, unmethylated GBM as measured by the ability to administer the vaccine to a patient

Feasibility of generating a personalized neoantigen DNA vaccine for patients with newly diagnosed, unmethylated GBM as measured by the ability to identify candidate tumor-specific neoantigens

Feasibility of generating a personalized neoantigen DNA vaccine for patients with newly diagnosed, unmethylated GBM as measured by the ability to manufacture a neoantigen-based DNA vaccine

+1 more

Secondary outcome measures

Immunogenicity of a personalized neoantigen DNA vaccine as measured by T-cell phenotype, myeloid derived suppressor cell frequency by flow cytometry

Immunogenicity of a personalized neoantigen DNA vaccine as measured by diversity of clonality from T cell receptor sequencing

Immunogenicity of a personalized neoantigen DNA vaccine as measured by putative antigen specificity from T cell receptor sequencing

+5 more

Trial Design

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,864 Total Patients Enrolled

17 Trials studying Glioblastoma

612 Patients Enrolled for Glioblastoma

Geneos TherapeuticsIndustry Sponsor

1 Previous Clinical Trials

36 Total Patients Enrolled

The Foundation for Barnes-Jewish HospitalOTHER

37 Previous Clinical Trials

6,772 Total Patients Enrolled

1 Trials studying Glioblastoma

37 Patients Enrolled for Glioblastoma

Media Library

Personalized neoantigen DNA vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04015700 — Phase 1

Glioblastoma Research Study Groups: Vaccine (GNOS-PV01 + INO-9012)

Glioblastoma Clinical Trial 2023: Personalized neoantigen DNA vaccine Highlights & Side Effects. Trial Name: NCT04015700 — Phase 1

Personalized neoantigen DNA vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04015700 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this research endeavor been undertaken before?

"CELLECTRA®2000 EP Device, supplied by Geneos Therapeutics has been studied since 2016 when it was first sponsored by Inovio Pharmaceuticals. After the successful completion of its Phase 1 trial involving 33 participants, this device is now being tested in 7 separate trials transpiring across 4 nations and 33 cities."

Answered by AI

Would it be possible to join this research endeavor currently?

"Unfortunately, this particular research endeavour is no longer actively looking for participants. It was first announced on July 14th 2020 and the last update saw it close its recruitment window in October 19th 2022. However, alternative studies are available; 442 clinical trials related to glioblastoma currently require volunteers, as well as seven CELLECTRA®2000 EP Device supplied by Geneos Therapeutics trails that need enrolment."

Answered by AI

What is the sample size for this investigation?

"This clinical trial has ended its recruitment process. After being posted on July 14th 2020 and edited October 19th 2022, the study is no longer seeking participants. However, there are currently 442 studies concerning glioblastoma as well as 7 trials involving Geneos Therapeutics' CELLECTRA®2000 EP Device actively searching for patients to participate."

Answered by AI

To what extent does CELLECTRA®2000 EP Device supplied by Geneos Therapeutics safeguard patients?

"Due to the limited amount of data currently available on its efficacy and safety, CELLECTRA®2000 EP Device supplied by Geneos Therapeutics received a score of 1."

Answered by AI

Have any prior experiments utilized the CELLECTRA®2000 EP Device from Geneos Therapeutics?

"Presently, there are 7 studies in operation looking into the efficacy of CELLECTRA®2000 EP Device produced by Geneos Therapeutics. Of these active trials, none have advanced to Phase 3 yet. While a majority of trials for this treatment are based out of Philadelphia, Pennsylvania, 60 medical facilities around the world are running tests on it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma

2020. "Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04015700.

All > Recurrent Glioblastoma > Glioblastoma Multiforme