A Trial to Evaluate the Safety and Efficacy of NCR300 in Preventing Recurrence of Acute Myeloid Leukemia（AML) After Transplantation

This is an open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of NCR300 injection.

Inclusion criteria

1.Subjects who understand and voluntarily sign the Informed Consent Form(ICF);

2.18-65years;

3.Clinical diagnosis of AML;

4.Accepted allogeneic blood stem cell transplantation within 60 to 28 days prior before initial infusion;

5.Complete donor chimerism and with high-risk recurrence factors prior to transplantation , or bone marrow examination shows positive MRD；

6.Have already recovered from the adverse reactions of previous treatment；

7.Having appropriate organ functions；

8.Eastern Cooperative Oncology Group(ECOG)<3;

9.Subjects who are able to comply with contraceptives from the study period to 6 months after the end of this study;

Exclusion criteria

• Bone marrow examination shows hematological recurrence;
• Have malignant tumors within 5 years before screening;
• Subjects with acute promyelocytic leukemia(APL);
• Subjects with severe respiratory diseases;
• Subjects with clear history of neurological or psychiatric disorders in the past;
• Active central nervous system involvement；
• HIV(human immunodeficiency virus) antibody positive,treponema pallidum(TP) antibody positive.Have active hepatitis B or hepatitis C;
• Allergies to NCR300 or its excipients;
• Subjects with active cardiovascular and cerebrovascular diseases;
• Received organ transplantation or planned transplantation；
• Received other treatment drugs after transplantation；
• Graft-Versus-Host Disease (GVHD)>II grades;
• Subjects with active nervous system autoimmune or inflammatory diseases;
• Expected survival period within 3 months;
• Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances;
• Having mental illness；
• Having uncontrollable active infections;
• Subjects whose state is not suitable for entering the study;
• Other situations determined by investigator that it is not suitable to enter the study.