OncoMatch/Clinical Trials/NCT07288112
DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma
Official title: Clinical Study of DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma
Is NCT07288112 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including DOC1021 and pIFN (peginterferon alfa-2a) for refractory melanoma.
Treatment: DOC1021 · pIFN (peginterferon alfa-2a) — 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: * Undergo a leukapheresis collection (take filgrastim subcutaneously x 5 doses, if clinically necessary, leading up to 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Melanoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy (anti-PD-1)
progressed following ≥1 prior systemic therapy including anti-PD-1 (i.e., refractory to anti-PD-1)
Lab requirements
Blood counts
Hemoglobin ≥ 8.0 gm/dL (transfusion/intervention allowed); ANC ≥ 1,500/mm3; Platelet count ≥ 75,000/mm3
Kidney function
Calculated creatinine clearance (CrCl) > 30 mL/min using Cockcroft and Gault formula
Liver function
Total bilirubin ≤ 1.5x ULN (≤ 3x ULN if Gilbert's); AST/ALT ≤ 3x ULN (≤ 5x ULN if liver metastases)
Adequate kidney, liver, bone marrow function, and immune function, as follows: Hemoglobin ≥ 8.0 gm/dL (use of transfusion or other intervention to achieve is acceptable); ANC ≥ 1,500 cells/mm3; Platelet count ≥ 75,000/mm3; Calculated creatinine clearance (CrCl) > 30 mL/min using Cockcroft and Gault formula; Total bilirubin ≤ 1.5 times upper limit of normal (ULN) except in patients with Gilbert's disease for which total bilirubin must be ≤ 3 times ULN; AST (SGOT) and ALT (SGPT) ≤ 3 times the ULN (or ≤ 5.0 × ULN if liver metastases)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Alabama at Birmingham · Birmingham, Alabama
- Banner MD Anderson Cancer Center · Gilbert, Arizona
- Arizona State University-Honor Health Research Institute · Scottsdale, Arizona
- City of Hope · Duarte, California
- Massachusetts General Hospital Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07288112 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages