NCT06805305

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

Randomized Study of DOC1021 Dendritic Cell Immunotherapy in Combination With Standard of Care for Newly Diagnosed Adult Glioblastoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Diakonos Oncology Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Glioblastoma (GBM)

Interventions

Type	Name	Description
BIOLOGICAL	DOC1021	Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method
PROCEDURE	Tumor resection	SOC brain tumor resection
DRUG	Temodar (Temozolomide)	SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation
RADIATION	SOC cranial radiation	60Gy radiation over 6 weeks in 2Gy fractions

Timeline

• Start date: 2025-03-17
• Primary completion: 2030-03-01
• Completion: 2032-03-01
• First posted: 2025-02-03
• Last updated: 2026-04-14

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study