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NCT07617285

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

RecruitingPHASE1

Study summary

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

At a glance

Conditions
AML, Refractory/Relapse Acute Myeloid Leukemia
Interventions
CAR-T cells chimeric antigen receptor T cells
Lead sponsor
Peking University People's Hospital
Target enrollment
27 participants
Age
18 Years70 Years
Sex
ALL
Locations
Peking University People's Hospital
Registry
View on ClinicalTrials.gov ↗

Eligibility criteria

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;