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

NCT06805305 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: DOC-GBM2
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 16

Brief 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

Conditions

Glioblastoma (GBM)

Keywords

Dendritic Cell Vaccine; Immunotherapy; Tumor vaccine

Outcome Measures

Primary Outcomes (1)

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

  5 years

Secondary Outcomes (5)

• Number of total participants treated with DOC1021 alive at one year post-GBM diagnosis date

  1 years

• Number of total participants treated with DOC1021 alive two years post-GBM diagnosis date

  2 years

• Number of total participants treated with DOC1021 alive three years post-GBM diagnosis date

  3 years

• Number of Participants with Adverse Events as Assessed by CTCAE v5.0

  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

  3 years

Other Outcomes (2)

• 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.

  5 years

• Neuro-cognitive function in all participants as Assessed by the Neurologic Assessment in Neuro-Oncology (NANO) scale

  5 years

Study Arms (2)

DOC1021 + pIFN + SOC

EXPERIMENTAL

DOC1021 administered by injection near deep-cervical lymph nodes + pIFN adjuvant with standard of care treatment

Biological: DOC1021; Procedure: Tumor resection; Drug: Temodar (Temozolomide); Radiation: SOC cranial radiation

SOC

ACTIVE COMPARATOR

Standard of Care treatment alone

Procedure: Tumor resection; Drug: Temodar (Temozolomide); Radiation: SOC cranial radiation

Interventions

SOC cranial radiation RADIATION

60Gy radiation over 6 weeks in 2Gy fractions

DOC1021 + pIFN + SOC; SOC

Temodar (Temozolomide) DRUG

SOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation

DOC1021 + pIFN + SOC; SOC

DOC1021 BIOLOGICAL

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

DOC1021 + pIFN + SOC

Tumor resection PROCEDURE

SOC brain tumor resection

DOC1021 + pIFN + SOC; SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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

You may not qualify 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.

Sponsors & Collaborators

• Diakonos Oncology Corporation: lead

Study Sites (16)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

City of Hope

Duarte, California, 91010, United States

RECRUITING

HOAG

Newport Beach, California, 92663, United States

RECRUITING

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

RECRUITING

Cooper University Health Care

Camden, New Jersey, 08103, United States

RECRUITING

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

RECRUITING

Atlantic Health

Summit, New Jersey, 07901, United States

RECRUITING

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37203, United States

RECRUITING

UTHealth Houston

Houston, Texas, 77030, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77057, United States

RECRUITING

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 41959823 DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

Transurethral Resection of Bladder; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: February 3, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2032
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)