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Trial Title:
A Trial to Evaluate the Safety and Efficacy of NCR300 in Preventing Recurrence of Acute Myeloid Leukemia（AML) After Transplantation
NCT ID:
NCT06441084
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Recurrence
Conditions: Keywords:
iNK
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
NCR300 injection
Description:
Subjects will receive at least 1 cycle of NCR300 injection.
Arm group label:
NCR300 injection
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
June 30, 2024
Completion date:
December 31, 2031
Lead sponsor:
Agency:
Nuwacell Biotechnologies Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Source:
Nuwacell Biotechnologies Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06441084
