SY001 Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors

Summary

Single-arm, dose-increasing setting study of CAR macrophages in Mesothelin overexpressing solid tumors.

Eligibility

Inclusion Criteria:

1. 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;
2. 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);
3. Eastern Cooperative Oncology Group (ECOG) score of 2 and satisfactory major organ functions;
4. Estimated life expectancy \>3 months;
5. 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.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection;
3. Patients who have a history of other mesothelin-targeting therapy;
4. Patients who have a history of autoimmune disease;
5. The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol.

Conditions3

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