A Clinical Study to Explore the Safety and Efficacy of CT0991 in Relapsed/ Refractory Acute Myeloid Leukemia

Exclusion Criteria

• •1. The participant has any serious illness, laboratory abnormality, or psychiatric disorder that may impair the ability to receive or tolerate planned trial treatment; or the investigator judges that the participant's participation in the clinical trial is not in his/her best interest (e.g.,compromised health), or may hinder, limit, or confound protocol-specific Assessments.
• •2. Participants were diagnosed with acute promyelocytic leukemia (APL),BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase),secondary AML (other than MDS), central nervous system leukemia.
• •3. Participants with a history of epilepsy or other central nervous system disease;
• •4. Participants who have previously received autologous or allogeneic CAR-T therapy.
• •5. Participants who have received autologous stem cell transplantation or allogeneic stem cell transplantation within 12 weeks.
• •6. Participants who have received prior immunotherapy targeting CD38.
• •7. Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD.
• •8. Participant has any of the following at screening:
• •1)Active, uncontrolled systemic infection or requiring intravenous anti-infective agents.
• •2)Any of the following cardiac conditions, including:
• •1. New York Heart Association Class III-IV heart failure;
• •2. History of myocardial infarction, coronary artery bypass grafting, or unstable angina within 6 months prior to Qinglin;
• •3. History of uncontrolled arrhythmia of significant clinical significance (as judged by the investigator), such as ventricular arrhythmia;
• •4. History of severe nonischemic ardiomyopathy;
• •5. Other cardiac disease that the investigatorbelieve could jeopardize the participant 's well-being or compromise participation in this clinical trial; 3) Active bleeding of clinical significance as judged by the investigator; 4)Requiring supplemental oxygen to maintain oxygen saturation\> 92%; 5)Patients with severe chronic obstructive pulmonary disease (COPD) or other lung diseases that cannot tolerate CAR-T treatment as judged by the investigator.