EX02 CAR-T Cells for Relapsed and Refractory Acute Myeloid Leukemia

Prior treatment

• Recipients of hematopoietic stem cell transplantation must have discontinued immunosuppressants for at least 6 weeks before enrollment and have no signs of graft-versus-host disease;

Other illness

• Active hepatitis A, B, C, HIV infection, or other severe active infections that are not yet controlled;
• History of acquired immune deficiency syndrome (AIDS) or long-term use of immunosuppressants due to other diseases (including steroids, equivalent to prednisone \>15mg/day);
• History of severe allergic reactions to any drugs planned for use in this study;
• Other conditions deemed unsuitable for participation in this trial by the investigator.

Lab values

• Conditions of the heart function: a. New York Heart Association (NYHA) class III or IV heart failure; b. Myocardial infarction or coronary artery bypass surgery within the six months prior to enrollment; c. Clinically significant ventricular arrhythmia or unexplained syncope; d. History of severe non-ischemic cardiomyopathy; e. History of cardiac dysfunction (left ventricular ejection fraction \<45%) within 8 weeks before enrollment;
• Severe liver or kidney dysfunction: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels exceeding 3 times the upper limit of normal, bilirubin exceeding 3 times the upper limit of normal; serum creatinine ≥ 178 μmol/L (decompensated phase);

Other

• Pregnant or lactating women; participants (both male and female) unwilling to use contraception;

• According to the Chinese Adult Acute Myeloid Leukemia (AML) Diagnosis and Treatment Guidelines (2023 edition/previous edition), patients diagnosed with acute myeloid leukemia (AML) and meeting the diagnostic criteria for refractory AML are eligible, including: initial treatment cases with no response after two courses of standard therapy; relapse within 12 months after achieving complete remission (CR) and failure of consolidation therapy; relapse after 12 months with no response to conventional chemotherapy; two or more relapses; and presence of extramedullary leukemia.
• Peripheral blood, bone marrow, or extramedullary lesion specimens showing leukemia cells with positive surface expression of EX02;
• ECOG performance status score of 0-2;
• Age ≥18 and ≤70 years, any gender;
• Blood cell examination meeting the following conditions: hemoglobin \> 60g/L, normal T lymphocyte count (CD3+) \> 0.5×10\^9/L, platelet count \> 30×10\^9/L;
• Negative pregnancy test for women of childbearing potential before the start of the trial, and agreement to use effective contraception measures during the trial until the final follow-up; male participants of reproductive potential agreeing to use effective contraception measures during the trial until the final follow-up;
• Voluntary participation in this clinical study: after fully understanding the study content, voluntary signing of the informed consent form, and commitment to complete all trial procedures and activities.