Treating Nectin-4-positive Advanced Breast Cancer with XKDCT293 (Nectin-4-CAR-T)

Exclusion Criteria

• •·Anyone who has any of the following conditions cannot be selected as a subject：
• •1. Pregnant or breastfeeding women;
• •2. Those who have a history of allergy to any component of the cell product ;
• •3. Suffering from other malignant tumors, except for the following: cured non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 5 years;
• •4. Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive, and HBV DNA copy number positive; Hepatitis C antibody (HCV-Ab) positive; Anti-Treponema pallidum antibody (TP-Ab) positive; Human immunodeficiency virus antibody (HIV-Ab) positive; Those who meet any of the following conditions;
• •5. Previous anti-tumor treatment or clinical trial participation:
• •1. Previously received CAR-T therapy or other gene-edited cell therapy;
• •2. Participated in other clinical studies within 28 days before reinfusion;
• •3. Received local radiotherapy within 7 days or at least 5 half-lives (whichever is longer) before apheresis or small molecule chemotherapy drugs;
• •4. Daily use of systemic glucocorticoids ≥ 15 mg within 7 days before apheresis, excluding inhaled corticosteroids;
• •5. Previously received Nectin-4 targeted therapy;
• •6. Live vaccine or live attenuated vaccine received within 4 weeks before single collection;
• •7. Surgery has been performed within 2 weeks before apheresis and the researchers believe that it may affect the patient's safety;
• •8. The investigators judged that there were comorbidities that required the use of systemic corticosteroids or other immunosuppressive drugs during the study;
• •9. Those who are known to have life-threatening hypersensitivity reactions or other intolerances to cyclophosphamide or fludarabine or severe allergic constitutions; those who have hypersensitivity constitutions, are allergic to human serum albumin, DMSO, etc.; those who are allergic to commonly used first aid and anesthetic drugs;
• •10. Suffering from any unstable circulatory system disease within 180 days prior to screening, including but not limited to unstable angina, myocardial infarction, heart failure \[New York Heart Association (NYHA) grade ≥ III\], severe arrhythmia requiring medication, or cardiac angioplasty, coronary artery stenting, or heart bypass surgery within 180 days prior to screening;
• •11. Uncontrolled diabetes (glycosylated hemoglobin\>8%), uncontrolled hypertension (systolic blood pressure/diastolic blood pressure\>160mmHg/100mmHg while taking medication);
• •12. Patients with active infection or uncontrollable infection requiring systemic treatment;
• •13. The presence or history of central nervous system disease, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the CNS;
• •14. Active autoimmune diseases (including but not limited to systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, Hashimoto's thyroiditis, etc., except for hypothyroidism that can be controlled only by hormone replacement therapy);
• •15. Bleeding and thrombotic tendency: clinically significant bleeding symptoms or clear bleeding tendency, such as bleeding gastric ulcer, within 90 days before screening; hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation disorder, hypersplenism, etc.); currently receiving thrombolytic or anticoagulant therapy; arterial/venous thrombotic events within 180 days before screening, such as cerebrovascular disease (including cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis and pulmonary embolism, etc.;
• •16. Acute toxicity caused by previous treatment has not recovered to grade 1 or below (except hematological toxicity, alopecia, and events judged to be tolerable by the investigator);
• •17. Those who have a history of psychotropic drug abuse and are unable to quit, or those with a history of mental disorders;
• •18. The researcher believes that the patient is not suitable for this clinical study (e.g., poor compliance, drug abuse, etc.).