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
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.
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
Parallel
DOC1021
Biological/VaccineDouble-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method
Tumor resection
Procedure/SurgerySOC brain tumor resection
Temodar (Temozolomide)
DrugSOC concomitant temozolomide during radiation and adjuvant temozolomide after radiation
SOC cranial radiation
Radiation60Gy radiation over 6 weeks in 2Gy fractions
Overall survival (time in months from randomization until death for each participant)
Number of total participants treated with DOC1021 alive at one year post-GBM diagnosis date
One-year survival
Number of total participants treated with DOC1021 alive two years post-GBM diagnosis date
2-year survival rate
Number of total participants treated with DOC1021 alive three years post-GBM diagnosis date
3-year survival
Number of Participants with Adverse Events as Assessed by CTCAE v5.0
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.
All items are scored 1 (worse outcome) to 4 (better outcome) or 1 (worse outcome) to 7 (better outcome). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Neuro-cognitive function in all participants as Assessed by the Neurologic Assessment in Neuro-Oncology (NANO) scale
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