Acute Myeloid Leukemia
Conditions
Keywords
iNK
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.
Interventions
BIOLOGICALNCR300 injection
Subjects will receive at least 1 cycle of NCR300 injection.
Sponsors
Beijing Friendship Hospital
Nuwacell Biotechnologies Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Limiting Toxicity(DLT) | 4 weeks after initial infusion | Number of participants with Dose-limiting toxicity in 28 days after first infusion |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactXiaowen Gong
Outcome results
None listed