eligibility_summary
Inclusion: women 18–70, HER2‑neg unresectable/metastatic BC, TNBC after 1L chemo or ER/PR+ after ≥1 endocrine/CDK4/6 failure, HLA‑A02:01, FAM53B‑219aa IHC+, measurable lesion, ECOG 0–1, ≥12‑wk survival, adequate organs, treatment washouts, no prior cell/vaccine therapy. Exclusion: rapid disease, active CNS mets, uncontrolled effusion/pain, recent other malignancy, serious CV/pulmonary/infection/thrombosis, autoimmune/immunodeficiency, active HBV/HCV/TB/syphilis, live vaccine, allogeneic transplant, ≥G2 neuropathy, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 single-arm study in HER2-negative advanced breast cancer testing: 1) CircFAM53B-219aa DC vaccine—an autologous dendritic cell (cellular) vaccine loaded with a circular RNA–encoded cryptic peptide (CircFAM53B-219aa), HLA-A02:01–restricted, mechanism: DC-mediated MHC-I presentation to prime antigen-specific CD8+ T cells against tumors with high CircFAM53B expression. 2) Camrelizumab—anti–PD-1 monoclonal antibody (IgG4) restoring T-cell activity by blocking PD-1. Targets/pathways: dendritic cells/APC function, TCR–peptide–MHC I axis, cytotoxic T lymphocytes, tumor cells expressing CircFAM53B-219aa, and the PD-1/PD-L1 checkpoint pathway.