Clinical Study of CD7 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory CD7-positive Peripheral T Cell Lymphoma

Exclusion Criteria

• •1. Primary cutaneous T-cell lymphoma, including mycosis fungoides (MF) and Sezary syndrome (SS); Enteropathy associated T-cell lymphoma (EATL), monotypic epitheliophagocytic intestinal T-cell lymphoma (MEITL), hepatosplenic T-cell lymphoma (HSTCL), extranodal NK/T-cell lymphoma, nasal type (EENKTCL) and primary central nervous system lymphoma and other types of T-cell leukemia/lymphoma.
• •2. Active central nervous system (CNS) invasion.
• •3. If anti-tumor treatment has been received before infusion, it should be excluded if any of the following conditions are met:
• •* received small molecule Targeted therapy within 72 hours
• •* Received systemic chemotherapy within 2 weeks (excluding pre-treatment)
• •* Received radiation therapy within 4 weeks
• •* When the time between the last monoclonal antibody infusion and those who have received monoclonal antibody treatment is less than 5 half-lives four weeks long or less (whichever is shorter)
• •4. Individuals with a history of allergies to any component in cellular products.
• •5. According to the New York Heart Association (NYHA) cardiac function grading standards, subjects with cardiac dysfunction classified as Class III or IV.
• •6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart disease clinically within 12 months of enrollment.
• •7. The electrocardiogram indicates that the QT interval is significantly prolonged, and the patient has serious heart disease such as serious arrhythmia in the past.
• •8. Previous history of craniocerebral trauma, Disorders of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.
• •9. Uncontrolled severe active infections (excluding simple urinary tract infections and bacterial pharyngitis).
• •10. The subject has a history of other primary cancers, except for the following:
• •1. Non Melanoma cured by excision, such as skin Basal-cell carcinoma;
• •2. Carcinoma in situ of cervix, local prostate cancer, and ductal Carcinoma in situ with disease-free survival ≥ 2 years after adequate treatment;
• •11. Subjects with autoimmune diseases requiring treatment or subjects requiring Immunosuppressive drug treatment;
• •12. Individuals with graft versus host disease (GvHD) and/or requiring immunosuppressive therapy.
• •13. Live vaccination within 4 weeks prior to screening.
• •14. The subject has a history of alcoholism, drug abuse, or mental illness.
• •15. Individuals with EBV DNA copy numbers greater than the upper limit of normal or positive for EBER; CMV copies greater than the upper limit of normal values; HBV or HCV DNA copy number\>the upper limit of normal value, and active syphilis or AIDS and other virus infected persons.
• •16. Subjects who were receiving systemic Sex hormone treatment before screening and who were judged by the investigator to need long-term use of systemic Sex hormone during treatment (except for inhalation or local use).
• •17. Individuals who have participated in other clinical trials within the first 4 weeks of screening.
• •18. Pregnant and lactating women and subjects with Fertility who cannot take effective contraceptive measures (both men and women).
• •19. Any situation that the researcher believes may increase the risk of the subject or interfere with the test results.