An Open-label, Single-arm Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of KT032 Cell Injection in Patients With Mesothelin-positive Advanced Solid Tumors.

Exclusion criteria

• ✕. Other malignancies within 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, or ductal carcinoma in situ of the breast after radical surgery;
• ✕. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA titer above the lower limit of detection of the quantitative assay at the study site; Hepatitis C virus (HCV) antibody positive with peripheral blood HCV RNA above the lower limit of detection of the quantitative assay at the study site; Human immunodeficiency virus (HIV) antibody positive; Positive syphilis test;
• ✕. Patients with central nervous system metastases and/or other unstable central nervous system diseases (hemorrhage, active infarction, infection, etc.);
• ✕. Receipt of live attenuated vaccine within 4 weeks prior to cell injection;
• ✕. History of hypersensitivity to prior immunotherapy, allergy or intolerance to fludarabine, cyclophosphamide, albumin-bound paclitaxel conditioning regimen drugs, or tocilizumab, or allergy to components of the investigational product formulation, or history of other severe allergic reactions;
• ✕. Poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) or clinically significant (e.g., active) cardiovascular disease, such as cerebrovascular accident (within 6 months prior to main informed consent signature), myocardial infarction (within 6 months prior to main informed consent signature), unstable angina, New York Heart Association (NYHA) Class II or greater congestive heart failure, or serious arrhythmia not controlled by medication or potentially affecting study treatment; Clinically significant abnormalities on ECG in 3 consecutive readings (at least 5 minutes apart each) or mean QTcB ≥450 ms;
• ✕. Other severe organic diseases or psychiatric disorders;
• ✕. Chronic obstructive pulmonary disease, interstitial lung disease, or clinically significant abnormal pulmonary function test results;