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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 6 months
Awards & highlights
Summary
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.
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.
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.
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 ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and tolerability of a personalized neoantigen DNA vaccine as measured by dose-limiting toxicities (DLTs)
Secondary study objectives
Number of high quality candidates neoantigens present in patients with newly diagnosed GBM
Progression-free survival (PFS) rate
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The personalized neoantigen-based vaccine for Glioblastoma works by stimulating the patient's immune system to recognize and attack tumor-specific antigens, which are unique to the cancer cells. This approach aims to enhance the body's natural defenses against the tumor.
Other common treatments for Glioblastoma include surgical resection to remove as much of the tumor as possible, radiation therapy to kill remaining cancer cells, and chemotherapy to target rapidly dividing cells. These treatments are crucial for Glioblastoma patients as they address the aggressive nature of the tumor, aiming to prolong survival and improve quality of life.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,974 Previous Clinical Trials
2,309,168 Total Patients Enrolled
17 Trials studying Glioblastoma
606 Patients Enrolled for Glioblastoma
Geneos TherapeuticsIndustry Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
The Foundation for Barnes-Jewish HospitalOTHER
40 Previous Clinical Trials
6,413 Total Patients Enrolled
2 Trials studying Glioblastoma
49 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can't have taken any other experimental drugs in the 4 weeks leading up to the study.You have had allergic reactions in the past to similar drugs or substances used in the study.You have a condition that causes frequent bleeding or clotting, which makes it unsafe to receive injections.You have tattoos, keloids, or raised scars close to where the treatment will be given.You have a serious condition in your brain that causes increased pressure or bleeding, uncontrolled seizures, or need urgent palliative care.You are able to perform daily activities and take care of yourself with a moderate level of energy and ability.If you need bevacizumab to help reduce swelling in your brain or to avoid taking high doses of corticosteroids, you will still be able to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Vaccine (GNOS-PV01 + INO-9012)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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