Clinical Trial

DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)

Recruiting Phase 2
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Summary
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
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2025-01-30; most recent amendment 2026-06-30.
Status change: Not Yet Recruiting → Recruiting 2025-03-20
Trial Details
NCT Number NCT06805305
Lead Sponsor Diakonos Oncology Corporation
Conditions Glioblastoma (GBM)
Enrollment 180 participants
Start Date 2025-03-17
Primary Completion 2030-03 (estimated)
Study Completion 2032-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-01