eligibility_summary
Eligibility: Adults 18–69 with HER2+ (IHC3+ or 2+/ISH+) advanced/metastatic solid tumors, refractory/intolerant to standard care, ≥1 measurable lesion ≤6 cm, ECOG ≤2, life ≥12 wks, adequate marrow/liver/renal function, LVEF ≥50%, SpO2>90%, negative pregnancy test and contraception. Key exclusions: prior CAR‑T/TCR, transplant history/plan, active infections (HBV/HCV/HIV/syphilis/TB), liver tumor ≥50%, recent steroids or systemic/antibody/IO/RT, CNS disease, serious CV/resp/autoimmune disease, recent major surgery, drug hypersensitivity, pregnancy, poor compliance/staff.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06101082: Phase 1, single-arm study of autologous anti-HER2 CAR-T cells (cellular gene therapy) for HER2+ locally advanced/metastatic solid tumors. Intervention: single IV infusion of anti-HER2 CAR-T (1×10^6, 3×10^6, or 1×10^7 CAR+ cells/kg, repeat dosing per investigator). Mechanism: patient T cells engineered with a HER2-specific chimeric antigen receptor bind HER2 (ERBB2) on tumor cells, triggering T-cell activation, cytokine release, and cytolytic killing. Preconditioning: cyclophosphamide (alkylating agent) and fludarabine (purine analog) for lymphodepletion to enhance CAR-T expansion. Targets/pathways: HER2/ERBB2 on tumor cells (e.g., breast, gastric, colorectal, pancreatic), immune effector T cells via CAR signaling, depletion of endogenous lymphocytes to support engraftment.