Safety and Efficacy of CD19 CAR-T/CAR-NK Cells

Exclusion Criteria

• •1. Patients with expected survival of less than 3 months.
• •2. Clinical findings (symptoms, signs, imaging, cerebrospinal fluid) of central nervous system leukemia.
• •3. Patients with hyperleukocytoemia (white blood cell count ≥50 x109 /L) or patients whose disease is progressing rapidly at the time of enrollment, as determined by the investigator, to be unable to ensure the completion of a full treatment cycle.
• •4. Patients with skin cancer other than melanoma or other primary tumors (such as cervical cancer, bladder cancer, breast cancer) (unless cured for more than 3 years).
• •5. Patients with infections including fungal, bacterial, viral or other uncontrolled infections or those requiring level 4 isolation.
• •6. Patients who test positive for HIV, HBV, HCV.
• •7. Patients with central nervous system diseases including stroke, epilepsy, dementia or autoimmune central nervous system diseases.
• •8. Myocardial infection, cardiac angiography or stenting, active angina pectoris or other obvious clinical symptoms, or cardiac asthma or cardiovascular lymphocyte infiltration in the 12 months prior to enrollment.
• •9. Those who are receiving anticoagulation therapy or have severe coagulation dysfunction.
• •10. According to the investigator's judgment, the drug treatment the patient is receiving will affect the safety and efficacy study of this project.
• •11. Patients with allergy or history of allergy to the biologics used in this project.
• •12. Pregnant or lactating women.
• •13. Systematic use of systemic or systemic steroid drugs within 2 weeks prior to treatment (except those who have recently or currently used inhaled steroids).
• •14. The efficiency of T cell transduction by replication-deficient lentivirus is less than 30%, or the ability to expand in response to CD3 / CD28 costimulatory signals is insufficient (\<5 times).
• •15. Those who have other uncontrolled diseases that the researchers consider unsuitable for enrollment.
• •16. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.
• •17. Patients who are also participating in other clinical studies.