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Recruiting Phase 1Phase 2 Interventional

DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma

ClinicalTrials.gov ID: NCT07288112

Public ClinicalTrials.gov record NCT07288112. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 7:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Clinical Study of DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT07288112
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Diakonos Oncology Corporation
Industry
Enrollment
35 participants

Conditions and interventions

Interventions

Biological · Procedure · Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 5, 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2032
Last update posted
Aug 11, 2026

2026 – 2033

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
The University of Alabama at Birmingham Birmingham Alabama 35233 Recruiting
Banner MD Anderson Cancer Center Gilbert Arizona 85234 Recruiting
Arizona State University-Honor Health Research Institute Scottsdale Arizona 85258 Recruiting
City of Hope Duarte California 91010 Recruiting
Massachusetts General Hospital Cancer Institute Boston Massachusetts 02114 Recruiting
Atlantic Health Morristown New Jersey 07960 Recruiting
University of North Carolina Chapel Hill North Carolina 27599 Recruiting
UT Southwestern Dallas Texas 75235 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07288112, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 11, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07288112 live on ClinicalTrials.gov.

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