Initial patient dosed at comprehensive cancer center City of Hope as Phase 2 trial prepares to expand to additional premier oncology centers nationwide
Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, today announced that the first patient has been dosed in its Phase 2 clinical trial evaluating DOC1021, an investigational patient-derived double-loaded dendritic cell therapy for glioblastoma (GBM), a highly aggressive primary brain tumor.
The first patient was dosed at City of Hope’s main campus in Los Angeles, California. City of Hope is one of the largest and most advanced cancer research and treatment organizations in the U.S. with its National Medical Center named top 5 in the nation for cancer by U.S. News & World Report.
“City of Hope leads groundbreaking clinical research that has resulted in therapies like CAR T cell immunotherapy and novel drug discoveries – new treatments that are addressing even the most challenging cancers. Glioblastoma is an aggressive tumor that is difficult to treat because the tumors often are resistant to existing treatments. We need to create more effective therapies for this deadly disease,” said Jana Portnow, M.D., City of Hope medical oncologist and co-director of its Brain Tumor Program.
This study (ClinicalTrials.gov Identifier: NCT06805305) is designed to evaluate the safety, tolerability, and efficacy of DOC1021 in combination with standard-of-care (SOC) treatment versus SOC alone in adult patients newly diagnosed with glioblastoma (IDH-wildtype). The trial is expected to open at approximately 20 centers in the United States, including Atlantic Health System and UTHealth Houston, that opened recently.
“We are tremendously proud to announce the dosing of the first patient in this critical Phase 2 study, marking an important milestone in our mission to develop a much-needed treatment for patients with glioblastoma, a disease that, despite significant advances in neuro-oncology, remains one of the most challenging cancers to treat, with patient outcomes still falling short of expectations,” said Dr. Laura Aguilar, Chief Medical Officer of Diakonos Oncology. “This Phase 2 trial represents an important step in evaluating DOC1021’s potential to enhance the immune response and work alongside standard therapies. We are optimistic that this approach could lead to meaningful improvements in survival and quality of life for patients facing this aggressive disease.”
The trial’s primary outcome measure is overall survival (OS), with 1-, 2- and 3-year survival as secondary outcome measures, along with progression-free survival (PFS), number of adverse events, health-related quality of life, and neuro-cognitive function.
“As Diakonos’ CDMO partner, we’re thrilled to see this next phase of clinical development take shape,” said Darren Head, CEO of Cellipont Bioservices. “Manufacturing patient-specific cell therapies like DOC1021 requires precision, flexibility, and deep scientific collaboration. We are proud to support Diakonos in advancing this novel immunotherapy and look forward to continuing our partnership as the trial progresses.”
