Glioblastoma (GBM)Phase 2NCT06805305
DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)
A Phase 2 study testing DOC1021, Tumor resection and Temodar (Temozolomide) in people with Glioblastoma (GBM), run by Diakonos Oncology Corporation at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- DOC1021, Tumor resection and Temodar (Temozolomide)
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 18 sitesUnited States
- Study dates
- 17 Mar 2025to Mar 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age 18 years or older
- Presumed diagnosis of glioblastoma IDH-wt (as per the 2021 WHO Classification of CNS Tumors) deemed to be potentially resectable and deemed to be a good candidate for post-operative standard of care temozolomide and radiation therapy.
- Surgical objective is for gross total resection (GTR)/near-total resection (NTR) de-fined as ≥ 95% of contrast enhancing (CE) tumor removed plus ≤ 1 cm3 residual CE tumor. Patients with subtotal resection will still be eligible if at least 70% of the CE tumor is resected.
- Eligibility will be confirmed after surgery when diagnosis of glioblastoma IDH-wt confirmed prior to randomization. Randomization can occur with only IDH1 immunohistochemistry and when additional molecular testing is available, if glioblastoma IDH-wt is not confirmed, the participant will be deemed a screen failure and replaced.
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- Patients with prior biopsy or subtotal resection are eligible if no other anti-cancer treatment received for glioblastoma and additional resection indicated.
- Ability to receive filgrastim (e.g., Neupogen), leukapheresis and 3 bi-weekly injections of DOC1021 near deep cervical lymph nodes + weekly pIFN x 6 weeks.
- Females of reproductive potential must have a negative serum pregnancy test and agree to use effective contraception (as determined appropriate for the patient by the investigator) during study treatment.
- Adequate kidney, liver, bone marrow function, and immune function, as follows:
- Hemoglobin ≥ 8.0 gm/dL
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelet count ≥ 75,000/mm3
- Calculated creatinine clearance (CrCl) > 30 mL/min using Cockcroft and Gault for-mula:
- For males = (140 - age[years]) x (body weight [kg]) / (72 x serum creatinine [mg/dL]) ii. For females = 0.85 x value from male formula e. Total bilirubin ≤ 1.5 times upper limit of normal (ULN) except in patients with Gilbert's disease for which total bilirubin must be ≤ 2 times ULN f. Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 3 times the ULN
- Karnofsky Performance Score ≥ 70
Who cannot join
- Infratentorial, recurrent, leptomeningeal or extracranial disease.
- Patients who are pregnant or breastfeeding.
- Known active HIV or hepatitis infection. Patients with HIV that is well-controlled and have undetectable viral titers remain eligible. Patients with history of HCV adequately treated such that RNA viral load is negative also remain eligible.
- Any severe or uncontrolled medical condition or other condition that could affect participation in this study as determined by the investigator, including but not limited to: uncontrolled or severe cardiac disease, systemic autoimmune disorders requiring immunosuppression in the past 2 years*, autoimmune hyper/hypothyroidism, untreated viral hepatitis, autoimmune hepatitis. *autoimmune disorders include but are not limited to rheumatoid arthritis, psoriasis and inflammatory bowel disease and immunosuppressive medications include DMARDs like methotrexate, TNF inhibitors, IL-6 receptor blockers, CD80/86 inhibitors, anti-CD20 and JAK inhibitors
- Treatment with another investigational drug or other experimental intervention within the last 30 days.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 17 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Indira Balmasheva, 877-338-7425, researchintegrity@dfci.harvard.edu
- Recruiting
Cooper University Health Care
Camden, New Jersey, 08103
Sean Behnke, 856-342-2362, Behnke-Sean@CooperHealth.edu
Alan Turtz, MD
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Claire Kowalczyk, 877-668-0683, cancerclinicaltrials@med.unc.edu
Dominique Higgins, MD
- Recruiting
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Clinical Research Coordinator, 800-293-5066, jamesline@osumc.edu
J. Bradley Elder, MD
- Recruiting
City of Hope
Duarte, California, 91010
Zorica Simic, 6262758069, info@coh.org
Jana Portnow, MD
- Active, not recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
- Recruiting
UTHealth Houston
Houston, Texas, 77030
Austin Lu, 7134868000, austin.lu@uth.tmc.edu
Nitin Tandon, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77057
Glenn Wilson, 713-798-2273, ggwilson@bcm.edu
Jacob Mandel, MD
- Recruiting
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Andres Alvarez, MD, 9042027713, CTOinterest@bmcjax.com
Robert Cavaliere, MD
- Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203
VICC CTIP (Clinical Trials Info Program), 800-811-8480, cip@vumc.org
Ryan Merrell, MD
- Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Xiaoru Chen, 732-235-2465, xc194@cinj.rutgers.edu
Morana Vojnic, MD
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Sara Massimo, 212-434-4482, smassimo@northwell.edu
John Boockvar, MD
- Recruiting
HOAG
Newport Beach, California, 92663
Julie Nguyen, 949-764-4577, julie.nguyen@hoag.org
Simon Khagi, MD
- Recruiting
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Theodore Estep, 878-261-6727, esteptj2@upmc.edu
Costas Hadjipanayis, MS, MD, PhD
- Recruiting
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Leti Velten, RN, 210-450-1921, Velten@uthscsa.edu
Andrew Brenner, MD, PhD
- Recruiting
UCSF
San Francisco, California, 94143
Stephanie Lewis, 415-353-2193, NeuroOncNewPatientCoord@ucsf.edu
Thomas Nelson, MD
- Recruiting
Atlantic Health
Summit, New Jersey, 07901
Morgan Finlay, 9085225985, Morgan.finlay@atlantichealth.org
Robert Aiken, MD
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Sara Cox, 336-713-7748, sara.cox@advocatehealth.org
Roy E Strowd III, MD
About this study
Official title: Randomized Study of DOC1021 Dendritic Cell Immunotherapy in Combination With Standard of Care for Newly Diagnosed Adult Glioblastoma
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:
Read more
- 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)
- Being tested
- DOC1021, Tumor resection, Temodar (Temozolomide), SOC cranial radiation
- Keywords
- Dendritic Cell Vaccine, Immunotherapy, Tumor vaccine
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOC1021Biological
Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method
Tumor resectionProcedure or surgery
SOC brain tumor resection
Temodar (Temozolomide)Drug
SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation
SOC cranial radiationRadiation
60Gy radiation over 6 weeks in 2Gy fractions
| Study group | Role | What they receive |
|---|---|---|
| DOC1021 + pIFN + SOC | Experimental | DOC1021 administered by injection near deep-cervical lymph nodes + pIFN adjuvant with standard of care treatment Receives: Biological: DOC1021; Procedure: Tumor resection; Drug: Temodar (Temozolomide); Radiation: SOC cranial radiation |
| SOC | Active comparator | Standard of Care treatment alone Receives: Procedure: Tumor resection; Drug: Temodar (Temozolomide); Radiation: SOC cranial radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (time in months from randomization until death for each participant)
Measured: 5 years
Secondary outcomes (5)
Number of total participants treated with DOC1021 alive at one year post-GBM diagnosis date
One-year survival
Measured: 1 years
Number of total participants treated with DOC1021 alive two years post-GBM diagnosis date
2-year survival rate
Measured: 2 years
Number of total participants treated with DOC1021 alive three years post-GBM diagnosis date
3-year survival
Measured: 3 years
Number of Participants with Adverse Events as Assessed by CTCAE v5.0
Measured: 3 years
Time in months from initial diagnosis of new diagnosed GBM until declared progression on imaging by RANO 2.0 criteria for all participants
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start17 Mar 2025
- Primary completionMar 2030 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonos Oncology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805305
- Sponsor's protocol ID
- DOC-GBM2
- Status last verified
- Jun 2026
- First submitted
- 14 Jan 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Georges JF, Clay C, Amin S, Goralczyk A, Mossop C, Bilbao CJ, Valeri A, Ifrach J, Zaher M, Colman L, Kohler L, Schumann EH, Vu M, Burns BA, Trivedi A, Liu W, Namekar M, Hofferek CJ, Ernste KJ, Bisht N, Vazquez-Perez J, Oyewole-Said D, Amanya SB, Rodriguez V, Kraushaar DC, Okoebor D, Bellayr I, Hartenbach J, Halpert MM, Duus EM, Aguilar LK, Hsu SH, Zhu JJ, Zvavanjanja RC, Bai Y, Kang SW, Jang HJ, Lee HS, Garg R, Esquenazi Y, Tandon N, Turtz A, Konduri V, Decker WK. Phase I Clinical Study of DOC1021 (dubodencel) for Adjuvant Immunotherapy of Glioblastoma. medRxiv [Preprint]. 2026 Apr 2:2026.03.28.26349013. doi: 10.64898/2026.03.28.26349013.
PubMed 41959823
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of DOC1021 Dendritic Cell Immunotherapy in Combination With Standard of Care for Newly Diagnosed Adult Glioblastoma
- ClinicalTrials.gov ID
- NCT06805305
- Acronym / sponsor ID
- DOC-GBM2
- Conditions
- Glioblastoma (GBM)
- Keywords
- Dendritic Cell Vaccine, Immunotherapy, Tumor vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Diakonos Oncology CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DOC1021 + pIFN + SOC | Experimental | Biological: DOC1021, Procedure: Tumor resection, Drug: Temodar (Temozolomide), Radiation: SOC cranial radiationDOC1021 administered by injection near deep-cervical lymph nodes + pIFN adjuvant with standard of care treatment |
| SOC | Active comparator | Procedure: Tumor resection, Drug: Temodar (Temozolomide), Radiation: SOC cranial radiationStandard of Care treatment alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age 18 years or older
- Presumed diagnosis of glioblastoma IDH-wt (as per the 2021 WHO Classification of CNS Tumors) deemed to be potentially resectable and deemed to be a good candidate for post-operative standard of care temozolomide and radiation therapy.
- Ability to receive filgrastim (e.g., Neupogen), leukapheresis and 3 bi-weekly injections of DOC1021 near deep cervical lymph nodes + weekly pIFN x 6 weeks.
Key exclusion criteria (5 listed)
- Infratentorial, recurrent, leptomeningeal or extracranial disease.
- Patients who are pregnant or breastfeeding.
- Known active HIV or hepatitis infection. Patients with HIV that is well-controlled and have undetectable viral titers remain eligible. Patients with history of HCV adequately treated such that RNA viral load is negative also remain eligible.
- Any severe or uncontrolled medical condition or other condition that could affect participation in this study as determined by the investigator, including but not limited to: uncontrolled or severe cardiac disease, systemic autoimmune disorders requiring immunosuppression in the past 2 years*, autoimmune hyper/hypothyroidism, untreated viral hepatitis, autoimmune hepatitis. *autoimmune disorders include but are not limited to rheumatoid arthritis, psoriasis and inflammatory bowel disease and immunosuppressive medications include DMARDs like methotrexate, TNF inhibitors, IL-6 receptor blockers, CD80/86 inhibitors, anti-CD20 and JAK inhibitors
- Treatment with another investigational drug or other experimental intervention within the last 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOC1021Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method | Biological | DOC1021 + pIFN + SOC |
| Tumor resectionSOC brain tumor resection | Procedure or surgery | DOC1021 + pIFN + SOC, SOC |
| Temodar (Temozolomide)SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation | Drug | DOC1021 + pIFN + SOC, SOC |
| SOC cranial radiation60Gy radiation over 6 weeks in 2Gy fractions | Radiation | DOC1021 + pIFN + SOC, SOC |
Primary outcome
Overall survival (time in months from randomization until death for each participant)
Time frame: 5 years
5 secondary outcomes
Number of total participants treated with DOC1021 alive at one year post-GBM diagnosis date
Time frame: 1 years
Number of total participants treated with DOC1021 alive two years post-GBM diagnosis date
Time frame: 2 years
Number of total participants treated with DOC1021 alive three years post-GBM diagnosis date
Time frame: 3 years
Number of Participants with Adverse Events as Assessed by CTCAE v5.0
Time frame: 3 years
Time in months from initial diagnosis of new diagnosed GBM until declared progression on imaging by RANO 2.0 criteria for all participants
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Derived from this study: PubMed 41959823Georges JF, Clay C, Amin S, Goralczyk A, Mossop C, Bilbao CJ, Valeri A, Ifrach J, Zaher M, Colman L, Kohler L, Schumann EH, Vu M, Burns BA, Trivedi A, Liu W, Namekar M, Hofferek CJ, Ernste KJ, Bisht N, Vazquez-Perez J, Oyewole-Said D, Amanya SB, Rodriguez V, Kraushaar DC, Okoebor D, Bellayr I, Hartenbach J, Halpert MM, Duus EM, Aguilar LK, Hsu SH, Zhu JJ, Zvavanjanja RC, Bai Y, Kang SW, Jang HJ, Lee HS, Garg R, Esquenazi Y, Tandon N, Turtz A, Konduri V, Decker WK. Phase I Clinical Study of DOC1021 (dubodencel) for Adjuvant Immunotherapy of Glioblastoma. medRxiv [Preprint]. 2026 Apr 2:2026.03.28.26349013. doi: 10.64898/2026.03.28.26349013.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DOC1021, Tumor resection and Temodar (Temozolomide) in people with Glioblastoma (GBM), run by Diakonos Oncology Corporation at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time in months from randomization until death for each participant) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06805305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.