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NCT06805305 · ClinicalTrials.gov registry record · Phase 2
DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)
A Phase 2 study of Glioblastoma (GBM), sponsored by Diakonos Oncology Corporation.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 13
- Study locations
NCT06805305: Recruiting Phase 2 study of Glioblastoma (GBM), sponsored by Diakonos Oncology Corporation.
NCT06805305 is a Phase 2 study of Glioblastoma (GBM) that is actively recruiting participants, run by Diakonos Oncology Corporation. The registered enrollment target is 180 participants, above the 61-participant average among 7 other Glioblastoma (GBM) trials with a reported enrollment target (195% higher). The trial reports 13 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06805305, a Phase 2 study of Glioblastoma (GBM), is actively recruiting participants, sponsored by Diakonos Oncology Corporation.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 13
- Study locations
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 |
What NCT06805305 shows while recruiting
NCT06805305 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 61-participant average among 7 other Glioblastoma (GBM) trials with a reported enrollment target (195% higher).
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.
NCT06805305 lists 13 locations in 8 states (Texas, California, New Jersey).
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).
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).
Who is sponsoring clinical trial NCT06805305?
This trial is sponsored by Diakonos Oncology Corporation, which has 3 total clinical trials registered on ClinicalTrials.gov.
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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