A-CAR028 治疗复发/难治性急性髓系白血病患者的研究

Inclusion Criteria:

* 18 to 75 years old at the time of signing the Informed Consent Form (ICF)
* More than 12 weeks of expected survival
* ECOG score 0 or 1
* Relapsed or refractory AML
* Adequate organ function

Exclusion Criteria:

* Acute Promyelocytic Leukemia (APL)
* Mixed Phenotype Acute Leukemia (MPAL)
* Acute Undifferentiated Leukemia (AUL)
* Only extramedullary leukemia
* Known allergies to the components or excipients of the A-CAR028 cell product
* Severe heart diseases, including but not limited to, myocardial infarction, angioplasty or stent implantation within 12 months prior to signing the ICF, unstable angina pectoris, severe arrhythmia, history of severe non-ischemic cardiomyopathy, heart failure
* Autologous or allogeneic hematopoietic stem cell transplantation within 3 months prior to signing the ICF
* Central nervous system (CNS) involvement or symptoms of CNS involvement (including cranial nerve lesions and extensive lesions or spinal cord compression)
* A stroke or seizure occurred within 12 months prior to signing the ICF
* Malignancy history within 5 years prior to signing the ICF
* Uncontrolled active infection
* Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive
* Live vaccine injection within 4 weeks prior to signing the ICF
* Acute or chronic graft-versus-host disease (GVHD) was present at screening
* Inadequate washing time for previous treatment
* Previously treated with CAR-T cell products or genetically modified T cell therapies

主要终点：Incidence of dose limiting toxicities (DLTs) · Throughout the 28 days post A-CAR028 infusion；Incidence and severity of Treatment Emergent Adverse Events (TEAEs) · Throughout the 3 months post A-CAR028 infusion
次要终点：Incidence and severity of Adverse Events (AEs)；Overall Response Rate (ORR): including Complete Response (CR), CR with Partial Hematologic Recovery (CRh), CR with Incomplete Hematologic Recovery (CRi), Morphologic Leukemia-free State (MLFS) and Partial Response (PR)；Duration of Response (DOR)；Event-free Survival (EFS)；Overall Survival (OS)；Maximal plasma concentration (Cmax)；Time to reach the maximal plasma concentration (Tmax)；Area under the curve within 28 days (AUC0-28d)

• A-CAR028 · EXPERIMENTAL · Autologous A-CAR028 administered by intravenous (IV) infusion

This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients