RecruitingPhase 1Phase 2NCT07288112

DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma

Clinical Study of DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma


Sponsor

Diakonos Oncology Corporation

Enrollment

35 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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: * Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis 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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new dendritic cell immunotherapy called DOC1021 in people with advanced melanoma whose cancer has stopped responding to anti-PD-1 immunotherapy (such as pembrolizumab or nivolumab). **You may be eligible if...** - You are 18 or older with unresectable or metastatic melanoma - Your melanoma has progressed after at least one course of anti-PD-1 therapy - You have at least one tumor that can be biopsied or removed to harvest enough tissue (at least 50 mg) - You are willing to pause anti-PD-1 therapy from enrollment until approximately 6 weeks after your first DOC1021 treatment **You may NOT be eligible if...** - You have not yet tried anti-PD-1 immunotherapy - You do not have accessible lesions for biopsy - You have active brain metastases or significant organ dysfunction - You cannot pause anti-PD-1 treatment safely Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDOC1021

Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method

PROCEDURETumor resection

Tumor resection or biopsy

DRUGpIFN (peginterferon alfa-2a)

pIFN 180 mcg subcutaneously every week for 4 total doses


Locations(2)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope

Duarte, California, United States

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NCT07288112


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