DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Diakonos Oncology Corporation
Study ID
NCT07288112
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Refractory Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DOC1021 — BIOLOGICAL
    Double-loaded dendritic cell vaccine, loaded with tumor lysate and mRNA using proprietary method
  • Tumor resection — PROCEDURE
    Tumor resection or biopsy
  • pIFN (peginterferon alfa-2a) — DRUG
    pIFN 180 mcg subcutaneously every week for 4 total doses

Study Details

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

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2031
Completion
Jan 31, 2033

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: DOC1021 + pIFN
    DOC1021 administered by injection near active tumor lesion lymph nodes + pIFN

Primary Outcome Measure

Phase I: To evaluate the number of dose limiting toxicities reported [ Time Frame: From time of first DOC1021 dose administration to 6 weeks later ]

Locations (2)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35233
Luke Hanna
[email protected]
205-644-2594
John Dubay, MD (PRINCIPAL_INVESTIGATOR)
City of HopeDuarteCalifornia91010
Doni Woo
[email protected]
626-218-1970
Yan Xing, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Alabama at Birmingham· Birmingham, ALCity of Hope· Duarte, CA

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