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Clinical Trials in the USA / NCT06805305
Recruiting Phase 2

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

NCT06805305 · tracked via the Priya Life Science USA tracker
Sponsor
Diakonos Oncology Corporation
Phase
Phase 2
Started
2025-03-17
Last updated
2026-07-01

Condition(s) studied

Glioblastoma (GBM)

Investigational drug(s) / intervention(s)

DOC1021Tumor resectionTemodar (Temozolomide)SOC cranial radiation

DOC1021: Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method

Tumor resection: SOC brain tumor resection

Temodar (Temozolomide): SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation

SOC cranial radiation: 60Gy radiation over 6 weeks in 2Gy fractions

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona Active Not Recruiting
City of Hope Duarte California Recruiting
HOAG Newport Beach California Recruiting
UCSF San Francisco California Recruiting
Baptist MD Anderson Cancer Center Jacksonville Florida Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Cooper University Health Care Camden New Jersey Recruiting
Rutgers Cancer Institute New Brunswick New Jersey Recruiting
Atlantic Health Summit New Jersey Recruiting
Lenox Hill Hospital New York New York Recruiting
UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina Recruiting
Wake Forest University Health Sciences Winston-Salem North Carolina Recruiting
The Ohio State University Comprehensive Cancer Center Columbus Ohio Recruiting
UPMC Presbyterian Hospital Pittsburgh Pennsylvania Recruiting
Vanderbilt-Ingram Cancer Center Nashville Tennessee Recruiting
UTHealth Houston Houston Texas Recruiting
Baylor College of Medicine Houston Texas Recruiting
The University of Texas Health Science Center at San Antonio San Antonio Texas Recruiting

More Diakonos Oncology Corporation trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06805305 on ClinicalTrials.gov ↗ ← All trials in the USA