Efficacy and Safety of CD19/CD20 CAR/TRuC-T in Relapsed/Refractory B-Cell Lymphoma

Exclusion Criteria

• •Subjects meeting any of the following criteria will be excluded:
• •1. History of allergy to any component of the cell product;
• •2. Abnormal complete blood count meeting any of the following: WBC ≤1 × 10⁹/L, ANC ≤0.5 × 10⁹/L, ALC ≤0.5 × 10⁹/L, or PLT ≤25 × 10⁹/L;
• •3. Laboratory abnormalities including, but not limited to, any of the following: total serum bilirubin ≥1.5 mg/dL; ALT or AST \>2.5 times the upper limit of normal; serum creatinine ≥2.0 mg/dL;
• •4. New York Heart Association (NYHA) Class III or IV heart failure, or left ventricular ejection fraction (LVEF) \<50% on echocardiography;
• •5. Abnormal pulmonary function, with oxygen saturation \<92% on room air;
• •6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;
• •7. Grade 3 hypertension with poor blood pressure control despite medication;
• •8. History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease;
• •9. Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy;
• •10. Presence of uncontrolled active infection;
• •11. Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;
• •12. Receipt of a live vaccine within 4 weeks prior to enrollment;
• •13. Positive for HIV, HBV, HCV, or TPPA/RPR, or HBV carrier status;
• •14. History of alcohol abuse, drug abuse, or psychiatric illness;
• •15. Participation in any other clinical study within 3 months prior to enrollment in this study;
• •16. Female subjects meeting any of the following conditions:
• •1. currently pregnant or breastfeeding;
• •2. planning to become pregnant during the study period; or
• •3. of childbearing potential and unwilling or unable to use effective contraception;
• •17. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.