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

NCT ID: NCT06441084

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2031-12-31

Brief Summary

A Trial to Evaluate the Safety and Efficacy of iNK in the Treatment of Subjects for Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation.

Detailed Description

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

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

NCR300 injection

Cohort1: Low dose NCR300 injection; Cohort2: Mid-low dose NCR300 injection; Cohort3: Mid-high dose NCR300 injection; Cohort4: High dose NCR300 injection.

Group Type: EXPERIMENTAL

NCR300 injection

Intervention Type: BIOLOGICAL

Subjects will receive at least 1 cycle of NCR300 injection.

Interventions

NCR300 injection

Subjects will receive at least 1 cycle of NCR300 injection.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: collaborator

Nuwacell Biotechnologies Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhao Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University

Central Contacts

Xiaowen Gong

Role: CONTACT

xwgong@nuwacell.com

15221195602

Other Identifiers

NCR300-2002

Identifier Type: -

Identifier Source: org_study_id