eligibility_summary
Eligible: Metastatic solid-tumor adenocarcinoma, measurable/evaluable disease, failed standard therapy, ECOG 0–1, can donate ~100 mL blood, weight ≥50 kg (men) or ≥35 kg (women), Hb ≥9 g/dL (≥10 by end of screening, no transfusion within 7 days), contraception and consent required. Exclude: symptomatic/needs-treatment brain mets, major cardio-cerebrovascular disease, HIV, active HBV/HCV, acute/severe infection, autoimmune disease, prior organ or stem-cell transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: SDH-Combi (Biological), an autologous adoptive cellular immunotherapy combining ex vivo–expanded natural killer (NK) cells and cytotoxic T lymphocytes (CTLs) for metastatic, treatment-refractory solid tumors. Mechanism of action: NK cells mediate innate, antigen-independent tumor killing via activating receptors (e.g., NKG2D/NCRs), antibody-dependent cellular cytotoxicity through CD16, and perforin/granzyme and death receptor (FasL/TRAIL) pathways. CTLs provide antigen-specific cytotoxicity via TCR recognition of tumor peptides on MHC class I with perforin/granzyme release and IFN-γ–mediated effects. Target cells/pathways: tumor cells expressing stress ligands and MHC I–presented tumor antigens, key effector pathways include cell-mediated cytolysis, ADCC, and proinflammatory cytokine signaling to remodel the tumor microenvironment.