Phase I Clinical Study of DOC1021 (dubodencel) for Adjuvant Immunotherapy of Glioblastoma.
J F Georges, C Clay, S Amin...
https://pubmed.ncbi.nlm.nih.gov/41959823Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06805305
Randomized Study of DOC1021 Dendritic Cell Immunotherapy Combined With Standard of Care for Newly Diagnosed Adult Glioblastoma
Led by Diakonos Oncology Corporation · Updated on 2026-04-23
180
Participants Needed
16
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying if adding DOC1021 dendritic cell immunotherapy and pIFN to the standard treatment for adults newly diagnosed with glioblastoma (IDH-wt) can improve survival. This Phase 2 trial also aims to evaluate the safety of this combined treatment compared to standard care alone. The study focuses on patients who have had surgery and are eligible for post-operative temozolomide chemotherapy and radiation therapy. Participants receiving DOC1021 and pIFN along with standard care will take filgrastim injections for 5 days followed by leukapheresis collection. They will get ultrasound-guided injections of DOC1021 near deep cervical lymph nodes every 2 weeks for a total of 3 doses and weekly pIFN injections for 6 weeks. Both treatment groups will continue to receive regular standard care including surgery, temozolomide chemotherapy, and radiation therapy. During the study, participants will visit the clinic regularly for quality of life assessments, symptom tracking, medication review, imaging scans, and blood tests. Researchers will monitor overall survival over 5 years and other outcomes such as adverse events, progression on imaging, and survival at 1, 2, and 3 years after diagnosis. Participation involves close monitoring and ongoing evaluations to assess treatment impact and safety throughout the study period.
CONDITIONS
Brief Title
DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Age 18 years or older
- Presumed diagnosis of glioblastoma IDH-wildtype suitable for surgery and post-operative temozolomide and radiation therapy
- Surgical goal is gross or near-total tumor removal, with eligibility confirmed after surgery
- Ability to receive filgrastim, leukapheresis, DOC1021 injections near deep cervical lymph nodes every 2 weeks for 3 doses, and weekly pIFN injections for 6 weeks
- Females of reproductive potential must have a negative pregnancy test and agree to use effective contraception during treatment
- Adequate kidney, liver, bone marrow, and immune function as defined by specific lab values
- Karnofsky Performance Score of 70 or higher
You will not qualify if you...
- Infratentorial, recurrent, leptomeningeal or extracranial glioblastoma
- Pregnant or breastfeeding women
- Active HIV or hepatitis infection (well-controlled HIV or treated hepatitis C are allowed)
- Severe or uncontrolled medical conditions affecting participation, including recent immunosuppressive treatment for autoimmune disorders
- Treatment with 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
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Tumor Resection
Duration - 1 day
Participants undergo surgical removal of the brain tumor as part of the standard of care.
1 visit (in-person)
Treatment
Duration - Approximately 6 to 8 weeks
Participants receive DOC1021 dendritic cell immunotherapy injections near deep-cervical lymph nodes every 2 weeks for 3 doses, weekly pIFN injections for 6 weeks, concomitant temozolomide during radiation, adjuvant temozolomide after radiation, and 6 weeks of cranial radiation therapy.
Weekly visits for up to 6 weeks, plus 3 injections every 2 weeks
Follow-up
Duration - Up to 5 years
Participants are monitored for survival and adverse events following completion of treatment.
Periodic visits depending on clinical status
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
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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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