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

Launched by NUWACELL BIOTECHNOLOGIES CO., LTD. · Jun 2, 2024

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• 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:
• • 1. Bone marrow examination shows hematological recurrence;
• • 2. Have malignant tumors within 5 years before screening;
• • 3. Subjects with acute promyelocytic leukemia(APL);
• • 4. Subjects with severe respiratory diseases;
• • 5. Subjects with clear history of neurological or psychiatric disorders in the past;
• • 6. Active central nervous system involvement；
• • 7. HIV(human immunodeficiency virus) antibody positive,treponema pallidum(TP) antibody positive.Have active hepatitis B or hepatitis C;
• • 8. Allergies to NCR300 or its excipients;
• • 9. Subjects with active cardiovascular and cerebrovascular diseases;
• • 10. Received organ transplantation or planned transplantation；
• • 11. Received other treatment drugs after transplantation；
• • 12. Graft-Versus-Host Disease (GVHD)\>II grades;
• • 13. Subjects with active nervous system autoimmune or inflammatory diseases;
• • 14. Expected survival period within 3 months;
• • 15. 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;
• • 16. Having mental illness；
• • 17. Having uncontrollable active infections;
• • 18. Subjects whose state is not suitable for entering the study;
• • 19. Other situations determined by investigator that it is not suitable to enter the study.

Trial Officials