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

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

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• 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

Locations (16)