Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)
NCT06805305 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- PROCEDURE Tumor resection
- BIOLOGICAL DOC1021
- DRUG Temodar (Temozolomide)
- RADIATION SOC cranial radiation
Study Locations (13)
Texas
- UTHealth Houston — Houston
- Baylor College of Medicine — Houston
- The University of Texas Health Science Center at San Antonio — San Antonio
California
- City of Hope — Duarte
- HOAG — Newport Beach
New Jersey
- Rutgers Cancer Institute — New Brunswick
- Atlantic Health — Summit
North Carolina
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill
- Wake Forest University Health Sciences — Winston-Salem
Arizona
- Banner MD Anderson Cancer Center — Gilbert
Florida
- Baptist MD Anderson Cancer Center — Jacksonville
Ohio
- The Ohio State University Comprehensive Cancer Center — Columbus
Pennsylvania
- UPMC Presbyterian Hospital — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2025-03-17 |
| Est. Completion | 2032-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06805305
The ClinicalTrials.gov registry entry for NCT06805305 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Diakonos Oncology Corporation, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Glioblastoma (GBM) appearing as the primary indexed condition, and to 4 interventions — of which Tumor resection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06805305 reports 13 study locations spanning 8 distinct geographic areas — top geographies include Texas, California, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06805305 about?
NCT06805305 is a clinical study titled "DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)". 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...
What is the current status of trial NCT06805305?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2025-03-17. Estimated completion is 2032-03.
What conditions does trial NCT06805305 study?
This clinical trial studies the following conditions: Glioblastoma (GBM). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06805305?
The interventions under investigation include: Tumor resection (PROCEDURE), DOC1021 (BIOLOGICAL), Temodar (Temozolomide) (DRUG), SOC cranial radiation (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06805305?
This trial is sponsored by Diakonos Oncology Corporation, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06805305 being conducted?
This trial has 13 study locations across Arizona, California, Florida, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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