Study of DOC1021 Dendritic Cell Immunotherapy With Standard Treatment for Adults Newly Diagnosed With Glioblastoma

What this Trial Is About

Researchers are evaluating whether adding DOC1021 dendritic cell immunotherapy combined with pIFN to the standard treatment for newly diagnosed adult glioblastoma IDH-wild type can improve survival. This phase 2 study compares this combination plus standard of care SOC against SOC alone, which includes surgery, temozolomide chemotherapy, and radiation. The safety of DOC1021 combined with pIFN is also being assessed. Participants in the DOC1021 pIFN SOC group will receive five doses of filgrastim injections followed by leukapheresis collection. They will then get ultrasound-guided DOC1021 injections near deep cervical lymph nodes every two weeks for three doses and weekly pIFN injections for six doses alongside. Both groups will continue to receive SOC treatment including surgery, chemotherapy, and radiation, with regular clinic visits. Throughout the study, participants will have frequent assessments including quality of life, symptom checks, medication use, imaging scans, and blood tests. Researchers will monitor overall survival over five years, adverse events, and disease progression using imaging criteria. The total participation includes treatment and long-term follow-up, ensuring thorough safety and efficacy evaluation.

DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)