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

Phase 1

Not yet recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Biological: NCR300 injection

• Registration Number: NCT06441084
• Lead Sponsor: Nuwacell Biotechnologies Co., Ltd.

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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-06-02
• Last Update Submitted: 2024-06-02
• Study First Posted: 2024-06-04
• Last Update Posted: 2024-06-04
• Study Start: 2024-06-30
• Primary Completion: 2028-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Adverse Event(AE) or Serious Adverse Event(SAE)	From the date of initial infusion to a year after initial infusion	Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Dose-Limiting Toxicity(DLT)	4 weeks after initial infusion	Number of participants with Dose-limiting toxicity in 28 days after first infusion

Secondary Outcome Measures

Name	Time	Method
Maximum plasma concentration(Cmax)	2 hours before initial infusion;4 hours ,24 hous, 3 Days after initial infusion.2 hours before second infusion; 24 hous, 3 Days after second infusion.	Maximum plasma concentration of NCR300 in peripheral blood
Time after doing at which maximun plasma concentration is reached(Tmax)	2 hours before initial infusion;4 hours ,24 hous, 3 Days after initial infusion.2 hours before second infusion; 24 hous, 3 Days after second infusion.	Time after doing at which maximun plasma concentration of NCR300 in peripheral blood is reached
Cumulative Incidence of Relapse(CIR)	6 Months After Initial Infusion	The proportion of patients with hematological recurrence within 6 months after initial infusion to all patients
Minimal Residual Disease(MRD)	From the date of screening to a year after initial infusion	Changes in MRD before and after treatment