An Exploratory Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SY001 Injection Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors
Single-arm, dose-increasing setting study of CAR macrophages in Mesothelin overexpressing solid tumors.
• Patients with pathologically diagnosed advanced ovarian cancer/pancreatic cancer who have failed at least 1 prior lines treatment, and tumor tissue samples were positive for mesothlin IHC staining;
• According to the RECIST 1.1, there is measurable tumor lesions (non-lymph node lesion 10mm in length or lymph node lesion 15mm in diameter measured by CT or MRI, with scan layer thickness 5mm);
• Eastern Cooperative Oncology Group (ECOG) score of 2 and satisfactory major organ functions;
• Estimated life expectancy \>3 months;
• Female patients of childbearing age must undergo a serum pregnancy test at screening and prior to pretreatment and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment.