Actively Recruiting
DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)
Led by Diakonos Oncology Corporation · Updated on 2026-04-23
180
Participants Needed
16
Research Sites
363 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed and dated informed consent
- Be willing to comply with all study procedures and be available for the study duration
- Be 18 years of age or older
- Have a presumed diagnosis of glioblastoma IDH-wildtype suitable for surgery and standard post-operative temozolomide and radiation therapy
- Be a candidate for gross total or near-total tumor resection (at least 70% tumor removal if subtotal resection)
- Have diagnosis confirmed after surgery before randomization
- Have received no other anti-cancer treatment for glioblastoma if previously biopsied or subtotal resection, and additional resection is planned
- Be able to receive filgrastim, leukapheresis, three bi-weekly DOC1021 injections near deep cervical lymph nodes, and six weekly pIFN injections
- Females of reproductive potential must have a negative pregnancy test and agree to use effective contraception during treatment
- Have adequate kidney, liver, bone marrow, and immune function, including hemoglobin ≥ 8.0 g/dL, neutrophils ≥ 1,500 cells/mm3, platelets ≥ 75,000/mm3, creatinine clearance > 30 mL/min, bilirubin ≤ 1.5 times upper limit of normal (or ≤ 2 times in Gilbert's disease), and liver enzymes ≤ 3 times upper limit of normal
- Have a Karnofsky Performance Score of 70 or higher
You will not qualify if you...
- Have infratentorial, recurrent, leptomeningeal, or extracranial disease
- Be pregnant or breastfeeding
- Have known active HIV or hepatitis infection (unless well-controlled HIV or treated hepatitis C with negative viral load)
- Have any severe or uncontrolled medical condition that could affect study participation, including uncontrolled cardiac disease, recent systemic autoimmune disorders requiring immunosuppression, autoimmune thyroid disorders, untreated viral or autoimmune hepatitis
- Have used another investigational drug or experimental intervention within the last 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
HOAG
Newport Beach, California, United States, 92663
Actively Recruiting
4
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Actively Recruiting
5
Cooper University Health Care
Camden, New Jersey, United States, 08103
Actively Recruiting
6
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
7
Atlantic Health
Summit, New Jersey, United States, 07901
Actively Recruiting
8
Lenox Hill Hospital
New York, New York, United States, 10075
Actively Recruiting
9
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
10
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
11
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
12
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
13
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
14
UTHealth Houston
Houston, Texas, United States, 77030
Actively Recruiting
15
Baylor College of Medicine
Houston, Texas, United States, 77057
Actively Recruiting
16
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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