# DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma

Clinical trial · Diakonos Oncology Corporation

- Archive id: nct:NCT07288112
- Published: 2025-12-17
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07288112
- Source URL: https://clinicaltrials.gov/study/NCT07288112
- Provenance: clinicaltrials

## 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 reproduced under 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._

## Trial details

- 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

Topics: [mRNA Therapeutics & Cancer Vaccines](https://space-kitty.com/topics/mrna-cancer-vaccines)

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