Clinical trial NCT06441084: A Trial to Evaluate the Safety and Efficacy of NCR300 in Preventing Recurrence of Acute Myeloid Leukemia（AML) After Transplantation
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Keywords: iNK
Lead sponsor: Nuwacell Biotechnologies Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Beijing Friendship Hospital
First posted: 2024-06-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Dose-Limiting Toxicity(DLT)
timeFrame: 4 weeks after initial infusion
measure: Adverse Event(AE) or Serious Adverse Event(SAE)
timeFrame: From the date of initial infusion to a year after initial infusion
Secondary outcomes:
measure: Maximum plasma concentration(Cmax)
timeFrame: 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.
measure: Time after doing at which maximun plasma concentration is reached(Tmax)
timeFrame: 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.
measure: Cumulative Incidence of Relapse(CIR)
timeFrame: 6 Months After Initial Infusion
measure: Minimal Residual Disease(MRD)
timeFrame: From the date of screening to a year after initial infusion
Other outcomes:
Locations:
Study officials:
affiliation: Capital Medical University
name: Zhao Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: