CELL INTELLIGENCE · 肿瘤细胞治疗研究

Inclusion Criteria:

1. Age 18-70 years (inclusive), male or female.
2. 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.
3. Bone marrow blasts ≥5% by morphology.
4. Estimated life expectancy \>12 weeks.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
6. Adequate organ function without ongoing supportive care, defined as:

   1. Cardiac: left ventricular ejection fraction (LVEF) ≥50%;
   2. Hepatic: ALT and AST ≤2.5 × upper limit of normal (ULN), and total bilirubin ≤2 × ULN;
   3. Renal: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula);
   4. 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:

1. Participants were diagnosed with acute promyelocytic leukemia (APL), BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase), central nervous system leukemia;
2. Participants with a history of epilepsy or other central nervous system disease;
3. Participants who have previously received autologous or allogeneic CAR-T therapy;
4. Participants who have received autologous stem cell transplantation or allogeneic stem cell transplantation within 12 weeks
5. Participants who have received prior immunotherapy targeting NKG2DL;
6. Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD;
7. 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;

主要终点：Adverse Events (AE) after CT0890B infusion · An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria · 12 months after CT890B infusion；Dose-limiting toxicity (DLT) · The DLT is evaluated as the proportion of patients who experienced adverse events related to CT0890B that meet the criteria for DLT events after the first infusion · Up to 28 days after CAR-T cells infusion；MTD and/or dose range · Evaluate Dose limited toxicity and recommended dosage range after CT0890B infusion · Up to 28 days after CAR-T cells infusion
次要终点：Composite response (CRc)；Partial response (PR)；Rate of Subsequent Stem Cell Transplantation After CAR-T Therapy；Duration of response (DOR)；Event-free survival (EFS)；Overall survival (OS)；Minimal Residual Disease (MRD) Negativity Rate；Pharmacokinetic Endpoint - Peak expansion (Cmax)

• CAR-T cells chimeric antigen receptor T cells · EXPERIMENTAL · CT0890B cells infusion

A Clinical Study to Investigate the Safety and Efficacy of CT0890B in Patients with Relapsed/Refractory Acute Myeloid Leukemia.