~90 spots leftby Mar 2030

Dendritic Cell Immunotherapy for Glioblastoma

Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Diakonos Oncology Corporation
No Placebo Group
Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if DOC1021 + pIFN alongside standard of care (SOC) will improve survival in adult patients newly diagnosed with glioblastoma (IDH-wt). It will also evaluate the safety of DOC1021 + pIFN. Researchers will compare DOC1021 dendritic cell immunotherapy regimen added to SOC compared to SOC treatment alone. Participants in the DOC1021 + pIFN + SOC arm will: * Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection * Undergo ultrasound guided perinodal DOC1021 injections every 2 weeks for a total of 3 doses * Receive subcutaneous pIFN injections weekly for a total of 6 doses in parallel with the DOC1021 injections Both arms of the trial will: - Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive SOC treatment with surgery, temozolomide chemotherapy and radiation

Eligibility Criteria

Adults diagnosed with a specific brain cancer called glioblastoma (IDH-wt) who haven't had other cancer treatments and are good candidates for surgery, chemotherapy, and radiation. They must be willing to follow the study plan and be available throughout the trial. Women of childbearing age need a negative pregnancy test and must use contraception.

Inclusion Criteria

I had a biopsy or partial surgery for glioblastoma without other cancer treatments.
I have signed the consent form for this trial.
I am not pregnant and agree to use birth control during the study.
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Treatment Details

Interventions

  • DOC1021 (Cancer Vaccine)
Trial OverviewThe trial is testing if adding DOC1021 dendritic cell immunotherapy plus pIFN to standard care improves survival in glioblastoma patients. Participants will receive injections of DOC1021, pIFN shots, filgrastim doses, leukapheresis collection, alongside regular treatment including surgery, Temodar chemo, and radiation.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: DOC1021 + pIFN + SOCExperimental Treatment4 Interventions
DOC1021 administered by injection near deep-cervical lymph nodes + pIFN adjuvant with standard of care treatment
Group II: SOCActive Control3 Interventions
Standard of Care treatment alone

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
City of HopeDuarte, CA
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Who Is Running the Clinical Trial?

Diakonos Oncology CorporationLead Sponsor

References