DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)

April 21, 2026 updated by: Diakonos Oncology Corporation

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:

  • 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center
        • Principal Investigator:
          • Ramya Tadipatri, MD
        • Contact:
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Principal Investigator:
          • Jana Portnow, MD
        • Contact:
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag
        • Principal Investigator:
          • Simon Khagi, MD
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Principal Investigator:
          • Robert Cavaliere, MD
        • Contact:
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper University Health Care
        • Contact:
        • Principal Investigator:
          • Alan Turtz, MD
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute
        • Principal Investigator:
          • Morana Vojnic, MD
        • Contact:
      • Summit, New Jersey, United States, 07901
    • New York
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Contact:
          • John Boockvar, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Principal Investigator:
          • Dominique Higgins, MD
        • Contact:
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
        • Principal Investigator:
          • Roy E Strowd III, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • J. Bradley Elder, MD
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Presbyterian Hospital
        • Contact:
        • Principal Investigator:
          • Costas Hadjipanayis, MS, MD, PhD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Vanderbilt-Ingram Cancer Center
        • Contact:
        • Principal Investigator:
          • Ryan Merrell, MD
    • Texas
      • Houston, Texas, United States, 77057
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • Jacob Mandel, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • UTHealth Houston
        • Principal Investigator:
          • Nitin Tandon, MD
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • The University of Texas Health Science Center at San Antonio
        • Contact:
        • Principal Investigator:
          • Andrew Brenner, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Age 18 years or older

  4. 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.

    1. 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.
    2. 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.
    3. Patients with prior biopsy or subtotal resection are eligible if no other anti-cancer treatment received for glioblastoma and additional resection indicated.
  5. 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.
  6. 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.

  7. Adequate kidney, liver, bone marrow function, and immune function, as follows:

    1. Hemoglobin ≥ 8.0 gm/dL
    2. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
    3. Platelet count ≥ 75,000/mm3
    4. Calculated creatinine clearance (CrCl) > 30 mL/min using Cockcroft and Gault for-mula:

    i. 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

  8. Karnofsky Performance Score ≥ 70

Exclusion Criteria:

  1. Infratentorial, recurrent, leptomeningeal or extracranial disease.
  2. Patients who are pregnant or breastfeeding.
  3. 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.
  4. 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
  5. Treatment with another investigational drug or other experimental intervention within the last 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DOC1021 + pIFN + SOC
DOC1021 administered by injection near deep-cervical lymph nodes + pIFN adjuvant with standard of care treatment
Biological: DOC1021
Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method
Procedure: Tumor resection
SOC brain tumor resection
Drug: Temodar (Temozolomide)
SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation
Radiation: SOC cranial radiation
60Gy radiation over 6 weeks in 2Gy fractions
Active Comparator: SOC
Standard of Care treatment alone
Procedure: Tumor resection
SOC brain tumor resection
Drug: Temodar (Temozolomide)
SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation
Radiation: SOC cranial radiation
60Gy radiation over 6 weeks in 2Gy fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival (time in months from randomization until death for each participant)
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of total participants treated with DOC1021 alive at one year post-GBM diagnosis date
Time Frame: 1 years
One-year survival
1 years
Number of total participants treated with DOC1021 alive two years post-GBM diagnosis date
Time Frame: 2 years
2-year survival rate
2 years
Number of total participants treated with DOC1021 alive three years post-GBM diagnosis date
Time Frame: 3 years
3-year survival
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
3 years
Number of Participants with Adverse Events as Assessed by CTCAE v5.0
Time Frame: 3 years
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life in all participants as assessed by EORTC Quality of Life Questionnaire Cancer QLC-C30 (Cancer 30-items) with QLQ-BN20 (Brain 20-items) module included.
Time Frame: 5 years
All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
5 years
Neuro-cognitive function in all participants as Assessed by the Neurologic Assessment in Neuro-Oncology (NANO) scale
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diakonos Oncology Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2025

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2032

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

February 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOC-GBM2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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