Human stem cell derived neurons
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Randomized Study of DOC1021 Dendritic Cell Immunotherapy in Combination with Standard of Care for Newly Diagnosed Adult Glioblastoma

This is a randomized phase 2 clinical trial evaluating the safety and efficacy of adding a type of immunotherapy called a dendritic cell vaccine to the standard of care for adult patients newly diagnosed with glioblastoma.

A dendritic cell is an immune cell that display antigens on its surface to induce an immune response. Dendritic cells can be genetically engineered to show the T cells how to recognize and destroy the tumor cells. The DOC1021 dendritic cell immunotherapy regimen consists of injections with dendritic cells from the patient that have been loaded with antigens specific to their own tumor and adjuvant pegylated interferon (pIFN)

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-wildtype (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) or near-total resection defined 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 is confirmed prior to randomization. Randomization can occur with only IDH1 immunohistochemistry and when additional molecular testing is available, if glioblastoma IDH-wildtype 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, plus weekly pIFN for 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 formula:
      1. For males = (140 – age[years]) x (body weight [kg]) / (72 x serum creatinine [mg/dL])
      2. For females = 0.85 x value from male formula
    5. Total bilirubin ≤ 1.5 times upper limit of normal (ULN) except in patients withGilbert’s disease for which total bilirubin must be ≤ 2 times ULN
    6. 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 a 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.
Investigator(s)

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