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Dendritic cell immunotherapy for glioblastoma treatment

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

Phase 2 Interventional Diakonos Oncology Corporation · NCT06805305

This study is testing if a new dendritic cell immunotherapy, given alongside standard treatments, can help adults newly diagnosed with glioblastoma live longer and feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorDiakonos Oncology Corporation Industry-sponsored
Drugs / interventionsradiation, methotrexate, chemotherapy, immunotherapy
Locations16 sites (Gilbert, Arizona and 15 other locations)
Trial IDNCT06805305 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of DOC1021 dendritic cell immunotherapy combined with standard of care (SOC) treatments in improving survival rates for adult patients newly diagnosed with glioblastoma (IDH-wt). Participants will receive a series of injections, including filgrastim, DOC1021, and pIFN, alongside regular SOC treatments such as surgery and chemotherapy. The study will compare outcomes between those receiving the immunotherapy regimen and those receiving SOC alone, while also monitoring safety and quality of life throughout the process.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a newly diagnosed, potentially resectable glioblastoma.

Not a fit: Patients who have received prior anti-cancer treatment for glioblastoma or those with non-resectable tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance survival outcomes for patients with glioblastoma.

How similar studies have performed: Other studies utilizing dendritic cell immunotherapy have shown promise, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Gilbert, Arizona and 15 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions GlioblastomaDendritic Cell VaccineImmunotherapyTumor vaccine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.