DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)
NCT ID: NCT06805305
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2025-03-17
2032-03-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DOC1021 + pIFN + SOC
DOC1021 administered by injection near deep-cervical lymph nodes + pIFN adjuvant with standard of care treatment
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
SOC
Standard of Care treatment alone
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Diakonos Oncology Corporation
INDUSTRY
Responsible Party
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Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope
Duarte, California, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
Atlantic Health
Summit, New Jersey, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
UTHealth Houston
Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Facility Contacts
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Danijela Covo
Role: primary
Zorica Simic
Role: primary
Lauren Anthony
Role: primary
Xiaoru Chen
Role: primary
Morgan Finlay
Role: primary
Claire Kowalczyk
Role: primary
Sara Cox
Role: primary
Clinical Research Coordinator
Role: primary
Theodore Estep
Role: primary
Mia Vu
Role: primary
Leti Velten, RN
Role: primary
Other Identifiers
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DOC-GBM2
Identifier Type: -
Identifier Source: org_study_id