eligibility_summary
Eligibility: Clonal plasma cell disorder (IgG/IgA/κ/λ MG, smoldering MM, or MM) confirmed ≥2x and persistent (immunofixation band or abnormal free κ/λ), ECOG ≤2, labs (Hb ≥9, ANC ≥1500, Plt ≥100k, bili <2.5×ULN, AST/ALT ≤2.5×ULN, CrCl ≥30). ≥PR and stable ≥90 d, washouts (PI/IMiD/steroids/low-dose Cy 14 d, chemo 28 d, ASCT 180 d, RT 14 d), consent. Exclude investigational agents, active myeloma Rx (bisphosphonates allowed), prior allo-SCT, uncontrolled illness, pregnancy/CBP/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Autologous dendritic cell DKK1 vaccine (biologic, cellular immunotherapy). Mechanism of action: Patient-derived dendritic cells are pulsed with DKK1 peptide to present this tumor-associated antigen and prime DKK1-specific T-cell responses (cytotoxic T lymphocytes) and potentially anti-DKK1 antibodies, driving immune elimination of malignant plasma cells. Targets: DKK1 (Dickkopf-1), a Wnt signaling antagonist overexpressed in myeloma with limited normal expression (prostate, placenta), malignant plasma cells/myeloma cells expressing DKK1, activation of dendritic cells and effector T cells. Exploratory pathway/biomarker: correlation of DKK1 and PD-L1 expression with response (PD-1/PD-L1 axis). Dosing: 5–10×10^6 DKK1-loaded DCs, three doses q2 weeks. Population: monoclonal gammopathy, smoldering/stable myeloma. Status: Withdrawn (PI left).