eligibility_summary
Inclusion: Women ≥18 with advanced TNBC, mesothelin+ by IHC, measurable disease (RECIST 1.1), progressed after ≥2 lines, ECOG 0–2, life expectancy ≥12 wks, adequate marrow/liver/renal function, negative pregnancy test and contraception. Exclusion: recent other cancers, uncontrolled CNS mets, effusions or pain, serious infections incl. HIV/HBV/HCV, recent thromboembolism or bleeding, significant CV disease, allergy to cells, recent trial, pregnant/lactating, unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: SZ011 CAR‑NK, a gene‑modified cellular immunotherapy using chimeric antigen receptor–engineered natural killer (NK) cells. Mechanism of action: NK cells are engineered with a CAR targeting mesothelin (MESO), CAR engagement on mesothelin‑positive TNBC cells activates NK cells to kill via cytotoxic degranulation (perforin/granzyme) and cytokine release, leading to tumor cell lysis. Dosing: IV infusion every 2 weeks with dose escalation (5×10^6 → 5×10^7 → 2×10^8 cells). Targets: mesothelin on tumor cells, NK cell effector pathways activated through CAR signaling. Population: advanced triple‑negative breast cancer with mesothelin expression.