Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma

Exclusion Criteria

• •1. History of allergy to any component in the cell product;
• •2. The following conditions in the blood routine examination: White blood cell count (WBC) ≤ 1×10⁹/L, absolute neutrophil count (ANC) ≤ 0.5×10⁹/L, absolute lymphocyte count (ALC) ≤ 0.5×10⁹/L, platelet count (PLT) ≤ 25×10⁹/L;
• •3. The following conditions in laboratory tests: including but not limited to, total serum bilirubin ≥ 1.5 mg/dl; serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the upper limit of normal; serum creatinine ≥ 2.0 mg/dl;
• •4. Patients with heart failure classified as grade III or IV according to the New York Heart Association (NYHA) classification criteria; or left ventricular ejection fraction (LVEF) \< 50% as detected by echocardiography;
• •5. Abnormal lung function with oxygen saturation \< 92% under room air;
• •6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically severe heart diseases within 12 months before enrollment;
• •7. Grade 3 hypertension with poorly controlled blood pressure despite drug treatment;
• •8. History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia or intracerebral hemorrhagic diseases;
• •9. Patients with autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive agent treatment;
• •10. Presence of uncontrolled active infection;
• •11. Previous use of any CAR-T cell product or other genetically modified T cell therapies;
• •12. Vaccination with live vaccines within 4 weeks before enrollment;
• •13. Subjects positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Treponema pallidum particle agglutination assay (TPPA)/rapid plasma reagin (RPR), as well as HBV carriers;
• •14. History of alcohol abuse, drug abuse, or mental illness in the subject;
• •15. The subject participated in any other clinical study within 3 months before joining this clinical study;
• •16. Female subjects with any of the following conditions: a) Currently pregnant or breastfeeding; or b) Having a pregnancy plan during the trial period; or c) Being fertile but unable to take effective contraceptive measures;
• •17. Other circumstances that, in the opinion of the investigator, make the subject unsuitable for participation in this study.