New hope for tough leukemia: experimental therapy CT1390B enters first human tests

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-70 years (inclusive), male or female 2. Relapsed or refractory acute myeloid leukemia definitively diagnosed as CLL-1 positive according to the WHO 2022 classification 3. Bone marrow blast percentage ≥5% by morphology 4. Estimated survival \> 12 weeks 5. ECOG score 0-2 6. Participants should meet the following test results (no ongoing supportive care) 1. Left ventricular ejection fraction (LVEF) \> 50% 2. ALT≤ 2.5 × ULN, AST ≤ 2.5 × ULN, total bilirubin ≤ 2 × ULN; ALT≤ 5 × ULN, AST ≤ 5 × ULN, total bilirubin ≤ 3 × ULN, if the liver is involved 3. Endogenous creatinine clearance ≥ 30 mL/min (creatinine clearance calculated using the Cockcroft-Gault formula) 4. 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), active 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 CLL-1 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 Lymphodepleting Chemotherapy; 3. History of uncontrolled arrhythmia of significant clinical significance (as judged by the investigator), such as ventricular arrhythmia; 4. History of severe non-ischemic cardiomyopathy; 5. Other cardiac disease that the investigator believe 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 8. Has HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis C virus infection (HCV antibody and HCV-DNA positive)