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

Inclusion Criteria:

1. According to the Chinese Adult Acute Myeloid Leukemia (AML) Diagnosis and TreatmentGuidelines (2023 edition/previous edition), patients diagnosed with acute myeloidleukemia (AML) and meeting the diagnostic criteria for refractory AML are eligible,including: initial treatment cases with no response after two courses of standardtherapy; relapse within 12 months after achieving complete remission (CR) andfailure of consolidation therapy; relapse after 12 months with no response toconventional chemotherapy; two or more relapses; and presence of extramedullaryleukemia.

2. Peripheral blood, bone marrow, or extramedullary lesion specimens showing leukemiacells with positive surface expression of EX02;

3. ECOG performance status score of 0-2;

4. Age ≥18 and ≤70 years, any gender;

5. Blood cell examination meeting the following conditions: hemoglobin > 60g/L, normalT lymphocyte count (CD3+) > 0.5×10^9/L, platelet count > 30×10^9/L;

6. Negative pregnancy test for women of childbearing potential before the start of thetrial, and agreement to use effective contraception measures during the trial untilthe final follow-up; male participants of reproductive potential agreeing to useeffective contraception measures during the trial until the final follow-up;

7. Voluntary participation in this clinical study: after fully understanding the studycontent, voluntary signing of the informed consent form, and commitment to completeall trial procedures and activities.

Exclusion Criteria:

1. Active hepatitis A, B, C, HIV infection, or other severe active infections that arenot yet controlled;

2. History of acquired immune deficiency syndrome (AIDS) or long-term use ofimmunosuppressants due to other diseases (including steroids, equivalent toprednisone >15mg/day);

3. Conditions of the heart function: a. New York Heart Association (NYHA) class III orIV heart failure; b. Myocardial infarction or coronary artery bypass surgery withinthe six months prior to enrollment; c. Clinically significant ventricular arrhythmiaor unexplained syncope; d. History of severe non-ischemic cardiomyopathy; e. Historyof cardiac dysfunction (left ventricular ejection fraction <45%) within 8 weeksbefore enrollment;

4. Pregnant or lactating women; participants (both male and female) unwilling to usecontraception;

5. Severe liver or kidney dysfunction: aspartate aminotransferase (AST) and alanineaminotransferase (ALT) levels exceeding 3 times the upper limit of normal, bilirubinexceeding 3 times the upper limit of normal; serum creatinine ≥ 178 μmol/L (decompensated phase);

6. History of severe allergic reactions to any drugs planned for use in this study;

7. Recipients of hematopoietic stem cell transplantation must have discontinuedimmunosuppressants for at least 6 weeks before enrollment and have no signs ofgraft-versus-host disease;

8. Other conditions deemed unsuitable for participation in this trial by theinvestigator.