Study to Evaluate the Safety and Preliminary Efficacy of CLL1 and CD38 Dual CAR-T in r/r AML

Exclusion Criteria

• •1. Diagnosis of acute promyelocytic leukemia;
• •2. clinical trial investigational drugs or cell therapies within 2 weeks or 5 half-lives ;
• •3. Acute myeloid leukemia of unknown lineage ;
• •4. Those who have active graft-versus-host disease (GVHD) at the time of enrollment or develop active acute or chronic GVHD within 4 weeks after enrollment or require immunosuppressive drugs to treat GVHD;
• •5. There is an active infection;
• •6. Suffering from other malignant tumors (except non-melanoma skin cancer and in situ cervical cancer, bladder cancer, and breast cancer with a disease-free survival period of more than 5 years);
• •7. The subject has had a stroke or epilepsy within 6 months before signing the informed consent form;
• •8. The subjects' cardiac function showed the following conditions:
• •1. New York Heart Association (NYHA) class III or IV heart failure;
• •2. Myocardial infarction or coronary artery bypass grafting (CABG) occurred within 6 months before signing the informed consent form;
• •3. A history of clinically significant ventricular arrhythmia or syncope of unknown origin (not caused by vasovagal or dehydration);
• •4. Have a history of severe non-ischemic cardiomyopathy;
• •5. Cardiac dysfunction (left ventricular \<35%) assessed by echocardiography or multiple gated acquisition scans, or other heart disease with clinical symptoms within 6 months before enrollment;
• •9. Active or previous central nervous system involvement, or clinically significant clinical manifestations of central nervous system involvement in subjects with acute myeloid leukemia ;
• •10. A positive virological test result for any of the following:
• •1. Human immunodeficiency virus antibodies (HIV antibodies);
• •2. Hepatitis C virus antibody (HCV antibody), those who are positive need to be tested for HCV-RNA, and those whose values are lower than the lower limit of the detection value can be enrolled;
• •3. HBsAg positive; or HBcAb positive; if HBcAb is positive, further testing of HBV DNA copy number is required . Those who are lower than the lower limit of the detection value can be enrolled;
• •4. Treponema pallidum antibodies (TPPA antibodies);
• •11. presence of pulmonary fibrosis;
• •12. Severe allergic history or allergic constitution;
• •13. The subject has undergone open injury or major surgery (referring to level III surgery and level IV surgery) within 2 weeks before signing the informed consent form, or plans to have surgery during the trial or within 2 weeks after reinfusion (excluding local anesthesia surgery) ;
• •14. for cyclophosphamide combined with fludarabine ;
• •15. Cannulae or drains other than central venous catheters;
• •16. Pregnant women, lactating women, or men who plan to give birth within 1 year of receiving treatment;
• •17. Any other circumstances that the researcher deems inappropriate for inclusion.