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

Nuwacell Biotechnologies

Status and phase: Not yet enrolling; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Biological: NCR300 injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06441084

NCR300-2002

Details and patient eligibility

About

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.

Full description

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

NCR300 injection

Experimental group

Description:

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

Treatment:

Biological: NCR300 injection