{"id":"nct:NCT07288112","kind":"trial","title":"DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma","authors":["Diakonos Oncology Corporation"],"author_count":1,"year":2025,"published":"2025-12-17","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT07288112","source_url":"https://clinicaltrials.gov/study/NCT07288112","archive_url":"https://space-kitty.com/papers/nct:NCT07288112","updated":"2026-09-09","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"The goal of this clinical trial is to learn if DOC1021 + pIFN will be safe and will lead to tumor responses in patients with refractory melanoma. DOC1021 is a dendritic cell immunotherapy derived from a patient's own blood cells and loaded with antigens from the patient's tumor in the form of tumor lysate and mRNA. The goal is to stimulate a T cell immune response that eliminates tumor cells. The study consists of two components: an initial phase I safety study to confirm safety/tolerability of the treatment regimen, and, subsequently, a single-arm phase II cohort to assess efficacy of the treatment regimen. All participants will: * Undergo a leukapheresis collection (take filgrastim subcutaneously x 5 doses, if clinically necessary, leading up to collection) * Receive two doses of DOC1021 under image guidance 2 weeks apart * Receive subcutaneous pIFN injections weekly for a total of 4 doses in parallel with the DOC1021 injections * Undergo an optional image-guided perinodal DOC1021 booster injection approximately 6 months after the first DOC1021 dose along with additional subcutaneous pIFN injections at time of the booster and the subsequent week for a total of 2 pIFN doses * Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive optional treatment with anti-PD1 agents","abstract_license":"ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":["Refractory Melanoma"],"details":{"acronym":null,"status":"RECRUITING","phase":"PHASE1, PHASE2","study_type":"INTERVENTIONAL","enrollment":35,"sponsor":"Diakonos Oncology Corporation","conditions":["Refractory Melanoma"],"interventions":["BIOLOGICAL: DOC1021","PROCEDURE: Tumor resection","DRUG: pIFN (peginterferon alfa-2a)"],"start_date":"2026-04-06","start_date_type":"ACTUAL","primary_completion_date":"2031-01-01","has_results":false,"data_source":"ClinicalTrials.gov","data_processed":"2026-10-29T09:00:05","modifications":"selected fields only; whitespace normalized; brief summary truncated to 2,000 characters"},"provenance":"clinicaltrials","attribution":"Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.","topics":[{"slug":"mrna-cancer-vaccines","name":"mRNA Therapeutics & Cancer Vaccines","domain_slug":"medicine"}],"cited_in_dossiers":[]}