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;
Pregnant or lactating women;
Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection;
Patients who have a history of other mesothelin-targeting therapy;
Patients who have a history of autoimmune disease;
Single group
SY001
DrugPBMC-derived anti-mesothelin Cheimeric Antigen Receptor macrophages
Identification of Maximum Tolerated Dose (MTD)
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
Objective response rate (ORR)
Treatment response was assessed according to the criteria of RECIST 1.1, with PET-CT scans being the primary method used to evaluate tumor progression.
Time to Peak (Tmax)
Changes in the CAR gene copy number after infusion of SY001; time to peak (Tmax) from 0 to 1 month.
Area Under the Plasma Concentration Versus Time Curve (AUC)
Changes in the CAR gene copy number after infusion of SY001, area under the concentration-time curve (AUC) from 0 to 1 month
Maximum Plasma Concentration of cytokines (Cmax)
Changes in cytokines in peripheral blood after infusion of SY001.
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