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

Acute Myeloid Leukemia Clinical Trial

Official title:

A Phase I or II Clinical Trial Evaluating the Safety and Efficacy of NCR300 Injection in Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441084
• Other study ID #: NCR300-2002
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 30, 2024
• Est. completion date: December 31, 2031

Study information

• Verified date: May 2024
• Source: Nuwacell Biotechnologies Co., Ltd.
• Contact: Xiaowen Gong
• Phone: 15221195602
• Email: xwgong[@]nuwacell.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Recurrence

Intervention

Biological:
• NCR300 injection
Subjects will receive at least 1 cycle of NCR300 injection.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nuwacell Biotechnologies Co., Ltd.	Beijing Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-Limiting Toxicity(DLT)	Number of participants with Dose-limiting toxicity in 28 days after first infusion	4 weeks after initial infusion
Primary	Adverse Event(AE) or Serious Adverse Event(SAE)	Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0	From the date of initial infusion to a year after initial infusion
Secondary	Maximum plasma concentration(Cmax)	Maximum plasma concentration of NCR300 in peripheral blood	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.
Secondary	Time after doing at which maximun plasma concentration is reached(Tmax)	Time after doing at which maximun plasma concentration of NCR300 in peripheral blood is reached	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.
Secondary	Cumulative Incidence of Relapse(CIR)	The proportion of patients with hematological recurrence within 6 months after initial infusion to all patients	6 Months After Initial Infusion
Secondary	Minimal Residual Disease(MRD)	Changes in MRD before and after treatment	From the date of screening to a year after initial infusion