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RecruitingInterventionalPhase 2

Randomized Study of DOC1021 Dendritic Cell Immunotherapy in Combination With Standard of Care for Newly Diagnosed Adult Glioblastoma

NCT ID: NCT06805305Sponsor: Diakonos Oncology CorporationLast updated: 2026-04-23

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

Arms & interventions

  • BiologicalDOC1021

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

  • ProcedureTumor resection

    SOC brain tumor resection

  • DrugTemodar (Temozolomide)

    SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation

  • RadiationSOC cranial radiation

    60Gy radiation over 6 weeks in 2Gy fractions

Outcome measures

Primary

  • Overall survival (time in months from randomization until death for each participant)

    Time frame: 5 years

Secondary

  • 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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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.

Study locations (16)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234

Recruiting
Ramya Tadipatri, MD · Principal Investigator

City of Hope

Duarte, California, 91010

Recruiting
Zorica Simic · Contact
Jana Portnow, MD · Principal Investigator

HOAG

Newport Beach, California, 92663

Recruiting
Julie Nguyen · Contact
Simon Khagi, MD · Principal Investigator

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207

Recruiting
Andres Alvarez, MD · Contact
Robert Cavaliere, MD · Principal Investigator

Cooper University Health Care

Camden, New Jersey, 08103

Recruiting
Alan Turtz, MD · Principal Investigator

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901

Recruiting
Morana Vojnic, MD · Principal Investigator

Atlantic Health

Summit, New Jersey, 07901

Recruiting
Robert Aiken, MD · Principal Investigator

Lenox Hill Hospital

New York, New York, 10075

Recruiting
Sara Massimo · Contact
John Boockvar, MD · Contact

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

Recruiting
Dominique Higgins, MD · Principal Investigator

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Recruiting
Roy E Strowd III, MD · Principal Investigator

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

Recruiting
Clinical Research Coordinator · Contact
J. Bradley Elder, MD · Principal Investigator

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213

Recruiting
Theodore Estep · Contact
Costas Hadjipanayis, MS, MD, PhD · Principal Investigator

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37203

Recruiting
Ryan Merrell, MD · Principal Investigator

UTHealth Houston

Houston, Texas, 77030

Recruiting
Nitin Tandon, MD · Principal Investigator

Baylor College of Medicine

Houston, Texas, 77057

Recruiting
Glenn Wilson · Contact
Jacob Mandel, MD · Principal Investigator

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

Recruiting
Leti Velten, RN · Contact
Andrew Brenner, MD, PhD · Principal Investigator

References

  • 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)