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

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.

This study was a single-arm, single-center, dose-increasing design, using the "3+3" approach for dose escalation, to evaluate the safety, tolerability and initial effectiveness of SY001, and to evaluate the pharmacokinetic characteristics, cytokines and the correlation between the efficacy of SY001.

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.