eligibility_summary
Include: Adults 18–70, >40 kg, ECOG 0–1, refractory advanced solid tumor, measurable lesion (RECIST 1.1), adequate organs, HER2+, WOCBP negative test. Exclude: recent therapy, transplant, pregnancy/lactation, active HBV/HCV/HIV/other infection, other cancer <5 yrs (some cured allowed), severe autoimmune/steroid use, severe allergy to prep drugs, unstable CV/organ disease, bleeding/thrombosis, significant effusions, CNS mets, psychiatric issues, recent trial/live vaccine, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: HER2-E-CART cells — an autologous, second‑generation chimeric antigen receptor T‑cell (CAR‑T) therapy. Mechanism of action: Patient T cells are engineered with an anti‑HER2 scFv linked to CD3ζ plus a co‑stimulatory domain (e.g., CD28 or 4‑1BB). Upon binding HER2 on tumor cells, the CAR triggers T‑cell activation, proliferation, cytokine release, and targeted cytotoxicity (perforin/granzyme) leading to tumor cell lysis. Administration: Intravenous infusion in a 3+3 dose‑escalation (low/medium/high), study references preconditioning, suggesting lymphodepletion to support T‑cell expansion. Targets: HER2 on tumor cell membranes, T‑cell activation pathways via CAR signaling (CD3ζ and co‑stimulation). Population: Adults with HER2‑positive, refractory advanced solid tumors, primary aim is safety/tolerability.