eligibility_summary
Eligibility: Adults (>=18) with unresectable/metastatic triple-negative breast cancer (ER/PR <=10% IHC, HER2-neg), accessible lesion for injection/biopsy, mesothelin >=10% IHC, ECOG 0-1, adequate organ function, SpO2 >92%, LVEF >=45%, consent/contraception. Exclude: other active cancers, active HBV/HCV/infection, autoimmune (neurologic) or systemic steroids >10 mg, excipient allergy, pregnant/breastfeeding, significant cardiac/lung disease, active CNS mets, inadequate ICI washout.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 (terminated for feasibility) testing huCART-meso, an autologous CAR T-cell therapy lentivirally transduced to express an anti-mesothelin M5 scFv linked to 4-1BB and CD3ζ signaling domains, delivered intratumorally (3×10^6 or 3×10^7 cells) in mesothelin-positive triple-negative breast cancer. Mechanism: CAR binding to mesothelin triggers T-cell activation (CD3ζ) and costimulation/persistence (4-1BB), driving targeted cytotoxicity and local immune modulation. Targets: mesothelin-expressing tumor cells, T-cell activation/costimulatory pathways. A lab-developed IHC test confirms mesothelin expression for eligibility.