Allogeneic CAR-T(CT0890B) in NKG2DL+ R/R AML

This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety, efficacy, and cellular pharmacokinetics of CT0890B in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 12~27 participants in this trial.

Inclusion criteria

• Age 18-70 years (inclusive), male or female.
• Relapsed or refractory acute myeloid leukemia (R/R AML) diagnosed according to the 2022 World Health Organization classification or ELN criteria, with confirmed NKG2D ligand-positive disease.
• Bone marrow blasts ≥5% by morphology.
• Estimated life expectancy >12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Adequate organ function without ongoing supportive care, defined as:

• Cardiac: left ventricular ejection fraction (LVEF) ≥50%;
• Hepatic: ALT and AST ≤2.5 × upper limit of normal (ULN), and total bilirubin ≤2 × ULN;
• Renal: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula);
• Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN.

c) Renal: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula); d) Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN.

Exclusion criteria

• Participants were diagnosed with acute promyelocytic leukemia (APL), BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase), central nervous system leukemia;
• Participants with a history of epilepsy or other central nervous system disease;
• Participants who have previously received autologous or allogeneic CAR-T therapy;
• Participants who have received autologous stem cell transplantation or allogeneic stem cell transplantation within 12 weeks
• Participants who have received prior immunotherapy targeting NKG2DL;
• Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD;
• 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:

• New York Heart Association Class III-IV heart failure;
• History of myocardial infarction, coronary artery bypass grafting, or unstable angina within 6 months prior to Qinglin;
• History of uncontrolled arrhythmia of significant clinical significance (as judged by the investigator), such as ventricular arrhythmia;
• History of severe nonischemic ardiomyopathy;
• 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;