Actively Recruiting
DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma
Led by Diakonos Oncology Corporation · Updated on 2026-04-14
35
Participants Needed
2
Research Sites
352 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Willing to comply with all study procedures and available for study duration
- Age 18 years or older
- Diagnosed with unresectable or metastatic melanoma progressed after at least one prior systemic therapy including anti-PD-1
- Willing and able to withhold anti-PD-1 treatment from enrollment through about 6 weeks after first DOC1021 dose
- One or more lesions available for biopsy or resection to obtain at least 50 mg tumor tissue and at least one measurable target tumor lesion
- Stable brain metastases after prior treatment allowed
- Ability to receive filgrastim, leukapheresis, perinodal DOC1021 injections, and weekly pIFN for 4 weeks
- Females of reproductive potential must have negative pregnancy test and agree to effective contraception during treatment
- Adequate kidney, liver, bone marrow, and immune function as specified
- ECOG Performance Score 0 or 1
You will not qualify if you...
- Pregnant or breastfeeding
- Known active HIV or hepatitis infection (well-controlled HIV or treated hepatitis C with negative viral load allowed)
- Severe or uncontrolled medical conditions affecting study participation including uncontrolled cardiac disease, systemic autoimmune disorders requiring immunosuppression, autoimmune thyroid disease, untreated viral hepatitis, autoimmune hepatitis
- Residual immune-related toxicities from prior immunotherapy above Grade 1 severity (except well-controlled endocrine toxicity)
- Treatment with another investigational drug or experimental intervention within last 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here