A Phase 1 Study of TRS005 in Patients With R/R CD20-positive B-NHL.

Exclusion Criteria

• •Patients who meet any of the following criteria will be excluded:
• •1. A clear history of drug allergy, and a history of ingredient allergy to heterogeneous proteins, biological agents or test drugs;
• •2. Active hepatitis B or C, or human immunodeficiency virus (HIV) antibody positive;
• •3. Those who are positive for syphilis antibodies and confirmed to be unresolved;
• •4. Tumor-infiltrating diseases of the central nervous system;
• •5. Accompanied by peripheral or central nervous system diseases;
• •6. Investigator-assessed diabetes uncontrolled by drug therapy;
• •7. Uncontrollable or symptomatic pleural/abdominal/pelvic effusion or pericardial effusion;
• •8. Patients with other malignancies within the past 5 years;
• •9. With active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, etc.);
• •10. Accompanied by the following serious cardiovascular diseases or central nervous system diseases:
• •1. Myocardial infarction in nearly 6 months of screening period;
• •2. Unstable angina pectoris in the screening period of nearly 3 months;
• •3. Cardiac insufficiency (cardiac function grade ≥ NYHA class II);
• •4. Severe arrhythmia (e.g., persistent ventricular tachycardia, ventricular fibrillation);
• •5. Prolonged QTc interval (male \> 450 ms, female \> 470 ms);
• •6. Second or third degree heart block;
• •7. Drug-poorly controlled hypertension (systolic blood pressure \> 160mmHg or diastolic blood pressure \> 100mmHg);
• •8. Cerebrovascular accident (CVA) or transient ischemic attack (TIA), etc., within 6 months before the administration.
• •11. Other serious diseases, including but not limited to active peptic ulcer, active hemorrhage, venous thromboembolic event (VTE) and severe interstitial lung disease;
• •12. Accompanied by other serious diseases and serious active infections (such as pneumonia, active tuberculosis, etc.);
• •13. Received hematopoietic growth factor treatment within 1 week prior to first administration, including colony stimulating factor, interleukin or blood transfusion;
• •14. The dosage of steroid hormone (prednisone phase equivalent) used greater than 20mg/ day within 1 month prior to first administration for more than 14 consecutive days or immunosuppressive treatment;
• •15. Various vaccines were inoculated within 1 month prior to first administration;
• •16. Major surgery (except diagnostic biopsy) within 1 month prior to first administration;
• •17. Patients who received autologous stem cell transplantation within 2 months prior to first administration;
• •18. Patients who have received allogeneic stem cell transplantation in the past;
• •19. Patients with infusion reaction above grade III after previous monoclonal antibody treatment;
• •20. Participate in clinical trials of other drugs or medical devices within 1 month prior to first administration;
• •21. Patients previously treated with CAR-T;
• •22. Investigators assessed as unsuitable to participate in this study for other reasons.