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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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.
• 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:
• 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
• Karnofsky Performance Score ≥ 70

You cannot join if

• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• DOC1021 (Biological): Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method
• Tumor resection (Procedure): SOC brain tumor resection
• Temodar (Temozolomide) (Drug): SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation
• SOC cranial radiation (Radiation): 60Gy radiation over 6 weeks in 2Gy fractions

Randomized · Parallel · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• surgery: Part of the study plan

Main goals

• Overall survival (time in months from randomization until death for each participant) (5 years)

Other goals

• Number of total participants treated with DOC1021 alive at one year post-GBM diagnosis date
• Number of total participants treated with DOC1021 alive two years post-GBM diagnosis date
• Number of total participants treated with DOC1021 alive three years post-GBM diagnosis date
• Number of Participants with Adverse Events as Assessed by CTCAE v5.0
• Time in months from initial diagnosis of new diagnosed GBM until declared progression on imaging by RANO 2.0 criteria for all participants

Planned enrollment: 180 (estimated).

• City of Hope, Duarte, California
• HOAG, Newport Beach, California
• UCSF, San Francisco, California
• Baptist MD Anderson Cancer Center, Jacksonville, Florida
• Dana-Farber Cancer Institute, Boston, Massachusetts
• Cooper University Health Care, Camden, New Jersey
• Rutgers Cancer Institute, New Brunswick, New Jersey
• Atlantic Health, Summit, New Jersey
• Lenox Hill Hospital, New York, New York
• UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina
• Wake Forest University Health Sciences, Winston-Salem, North Carolina
• The Ohio State University Comprehensive Cancer Center, Columbus, Ohio
• UPMC Presbyterian Hospital, Pittsburgh, Pennsylvania
• Vanderbilt-Ingram Cancer Center, Nashville, Tennessee
• UTHealth Houston, Houston, Texas
• Baylor College of Medicine, Houston, Texas
• The University of Texas Health Science Center at San Antonio, San Antonio, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

These papers are listed in the registry record. Unless a paper is marked as about this trial, it is background research on the treatment or disease, not results from this study.

• Publication about this trial (to be verified before citing)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.

• ClinicalTrials.gov NCT06805305

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jun 30, 2026. Public record; not medical advice.