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DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma

NCT07288112 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-04-14

No results posted yet for this study

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

Conditions

  • Refractory Melanoma

Interventions

BIOLOGICAL

DOC1021

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

PROCEDURE

Tumor resection

Tumor resection or biopsy

DRUG

pIFN (peginterferon alfa-2a)

pIFN 180 mcg subcutaneously every week for 4 total doses

Sponsors & Collaborators

  • Diakonos Oncology Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2031-01-31
Completion
2033-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07288112 on ClinicalTrials.gov