Personalized DNA Vaccine for Glioblastoma

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

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Washington University School of Medicine

Must not be taking: Immunotherapy, Investigational agents

Disqualifiers: Other malignancy, Immunodeficiency, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

9 Participants Needed

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.

Research Team

Tanner M Johanns, M.D., Ph.D.

Principal Investigator

Washington University School of Medicine

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.

Inclusion Criteria

Patients who had prior craniotomy with biopsy, subtotal resection, total gross resection, or re-resection will be permitted.

Consent to genome sequencing and dbGaP-based data sharing and has provided or will provide germline (PBMC) and tumor DNA/RNA samples of adequate quality for sequencing. (Acquisition of specimens for sequencing and the sequencing itself may be done as part of routine care or another research project.)

Normal bone marrow and organ function as defined below:

Exclusion Criteria

No candidate neoantigen identified during screening.

Inadequate tissue acquisition to allow for neoantigen screening.

Known allergy, or history of serious adverse reaction to, vaccines such as anaphylaxis, hives, or respiratory difficulty.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Standard radiation therapy administered per standard of care

Treatment

Participants receive GNOS-PV01 + INO-9012 on Days 1, 22, and 43 of Cycle 1 and then on Day 1 of each subsequent cycle

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Personalized neoantigen DNA vaccine

Trial Overview 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.

Participant Groups

Group I: Vaccine (GNOS-PV01 + INO-9012) Experimental Treatment 3 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:

• Pediatric recurrent brain tumors

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Geneos Therapeutics

Industry Sponsor

Trials

2

Recruited

50+

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials

43

Recruited

6,600+