First Patients Dosed With DOC1021 in Phase 1/2 Melanoma Trial

The first patients have been dosed with DOC1021 (dubodencel), an investigational dendritic cell therapy, in a phase 1/2 trial for patients with refractory melanoma, according to a news release from Diakonos Oncology Corp.¹

Patients were treated at City of Hope in Duarte, California, and the University of Alabama at Birmingham (UAB), marking the transition of the DOC-RM study (NCT07288112) into active clinical evaluation. The trial recently was featured as a trial-in-progress presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

“The design of this trial offers the opportunity to study an investigational dendritic cell immunotherapy without the need for preconditioning chemotherapy or high-dose IL-2,” John Dubay, MD, assistant professor in the Department of Medicine, Division of Hematology and Oncology, and principal investigator at UAB, stated in the news release. “The ability to administer DOC1021 in an outpatient setting may also help streamline treatment delivery and broaden patient access. We’re pleased to begin treating patients and participating in this important study.”

Trial Design

DOC-RM is a multicenter study evaluating the safety, immune activity, and preliminary clinical efficacy of DOC1021 in patients with unresectable or metastatic melanoma who have progressed after prior therapies, including anti–PD-1 treatment. Patients receive 2 courses of DOC1021 in combination with pegylated interferon, with an optional booster dose approximately 6 months later. Patients must have at least 1 prior systemic therapy including anti–PD-1 and have 1 or more lesions available for biopsy or resection to yield tumor tissue for generating DOC1021, with at least 1 target lesion measurable after DOC1021.²

Primary and secondary end points include safety, objective response, circulating tumor DNA (ctDNA), and immune biomarkers measured in tumor and peripheral blood. Initial safety, biomarker, and clinical activity results are anticipated in the fourth quarter of 2026, per the release. The trial is currently enrolling at City of Hope, UAB, Massachusetts General Hospital, Banner MD Anderson Cancer Center, UT Southwestern, HonorHealth Research Institute, University of North Carolina, and Atlantic Health, and is supported by Diakonos Oncology along with a Product Development Research Grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

Mechanism and Broader Development Context

DOC1021 is a first-in-class, double-loaded dendritic cell therapy derived from the patient’s cells, engineered to promote a broad, personalized antitumor immune response, enabling presentation of the full spectrum of tumor antigens using a combination of tumor lysate and amplified tumor-derived mRNA from each patient’s tumor with autologous dendritic cells. According to the company, this double-loading approach is designed to mimic natural immune activation that occurs during viral infection, without requiring molecular modification or genetic engineering of immune cells, lymphodepleting chemotherapy, or high-dose interleukin-2, allowing for outpatient administration. The approach builds on preclinical data showing antitumor activity across multiple tumor models.

The FDA granted fast track designation to DOC1021 for unresectable or metastatic cutaneous melanoma in May 2026. Diakonos is also evaluating DOC1021 in a phase 1 pancreatic cancer trial (NCT04157127) and a phase 2 glioblastoma trial (NCT06805305); the FDA has granted fast track designation to DOC1021 across all 3 indications, and the company received orphan drug designation for the glioblastoma program in January 2024.

“Patients whose melanoma progresses following anti-PD-1 therapy continue to face limited treatment options, highlighting the need for new immunotherapeutic strategies,” Yan Xing, MD, PhD, associate professor in the Department of Medical Oncology & Therapeutics Research and principal investigator at City of Hope, stated in the news release. “DOC1021 is designed to utilize each patient’s own tumor antigens to generate an individualized immune response. We’re excited to evaluate this investigational approach and contribute to the clinical development of DOC1021.”

REFERENCES

1. Diakonos Oncology Announces First Patients Dosed in Phase 1/2 DOC-RM Study of DOC1021 in Refractory Melanoma. News release. Diakonos Oncology Corp. July 30, 2026. Accessed July 30, 2026. https://tinyurl.com/5byfk8x3

2. DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma. ClinicalTrials.gov. Updated July 20, 2026. Accessed July 31, 2026. https://clinicaltrials.gov/study/NCT07288112