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

NCT06805305 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-04-23

No results posted yet for this study

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

RADIATION

SOC cranial radiation

60Gy radiation over 6 weeks in 2Gy fractions

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

Sponsors & Collaborators

  • Diakonos Oncology Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2030-03-31
Completion
2032-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06805305 on ClinicalTrials.gov