Dendritic Cell Immunotherapy for Treatment of Adult GBM

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for theduration of the study

3. Age 18 years or older

4. Presumed diagnosis of GBM deemed to be potentially resectable and deemed to be agood candidate for postoperative standard of care temozolomide and radiationtherapy.

5. The surgical objective is for gross total resection (GTR)/near-total resection (NTR) defined as greater than or equal to 95% of contrast enhancing (CE) tumorremoved plus less than or equal to 1 cm3 residual CE tumor. Patients withsubtotal resection will still be eligible if at least 70% of the CE tumor isresected.

6. Eligibility will be confirmed after surgery when diagnosis of GBM IDH-wtconfirmed prior to randomization.

7. Patients with prior biopsy or subtotal resection are eligible if no otheranti-cancer treatment received for glioblastoma and additional resectionindicated.

8. Ability to receive filgrastim (e.g. Neupogen), leukapheresis and 3 bi-weeklyinjections of DOC1021 near deep cervical lymph nodes + weekly pIFN x 6 weeks.

9. Females of reproductive potential must have a negative serum pregnancy test andagree to use effective contraception (as determined appropriate for the patient bythe investigator) during study treatment.

10. Adequate kidney, liver, bone marrow function, and immune function, as follows:

11. Hemoglobin ≥ 8.0 gm/dL (use of transfusion or other intervention to achieve isacceptable)

12. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3

13. Platelet count ≥ 75,000/mm3

14. Calculated creatinine clearance (CrCl) > 30 mL/min using Cockcroft and Gaultformula: 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 ≤ 1.5times upper limit of normal (ULN) except in patients with Gilbert's disease forwhich total bilirubin must be ≤ 2 times ULN f. Aspartate transaminase AST (SGOT) andalanine aminotransferase ALT (SGPT) ≤ 3 times the ULN

15. Karnofsky Performance Score ≥ 70

Exclusion Criteria:

1. Multifocal, deep midline, infratentorial, recurrent, leptomeningeal or extracranialdisease.

2. Patients who are pregnant or breastfeeding.

3. Known active HIV or hepatitis infection. Patients with HIV that is well-controlledand have undetectable viral titers remain eligible. Patients with history of HCVadequately treated such that RNA viral load is negative also remain eligible.

4. Any severe or uncontrolled medical condition or other condition that could affectparticipation in this study as determined by the investigator, including but notlimited to uncontrolled or severe cardiac disease, systemic autoimmune disordersrequiring immunosuppression in the past 2 years, autoimmune hyper/hypothyroidism,untreated vi-ral hepatitis, autoimmune hepatitis.

5. Treatment with another investigational drug or other experimental interventionwithin the last 30 days.