DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (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 glioblastoma IDH-wt (as per the 2021 WHO Classification of CNSTumors) deemed to be potentially resectable and deemed to be a good candidate forpost-operative standard of care temozolomide and radiation therapy.

5. Surgical objective is for gross total resection (GTR)/near-total resection (NTR) de-fined as ≥ 95% of contrast enhancing (CE) tumor removed plus ≤ 1 cm3residual CE tumor. Patients with subtotal resection will still be eligible ifat least 70% of the CE tumor is resected.

6. Eligibility will be confirmed after surgery when diagnosis of glioblastomaIDH-wt confirmed prior to randomization. Randomization can occur with only IDH1immunohistochemistry and when additional molecular testing is available, ifglioblastoma IDH-wt is not confirmed, the participant will be deemed a screenfailure and replaced.

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

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 Gaultfor-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 ≤ 1.5times 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. 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-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 viral hepatitis, autoimmune hepatitis. *autoimmune disorders include butare not limited to rheumatoid arthritis, psoriasis and inflammatory bowel diseaseand 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 interventionwithin the last 30 days.