OncoMatch/Clinical Trials/NCT07288112
DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma
Is NCT07288112 recruiting? Yes, currently enrolling (May 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: * 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-pd-1 therapy
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 disease); AST and 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 · Birmingham, Alabama
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