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| Name | Class |
|---|---|
| Beijing Friendship Hospital | OTHER |
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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.
This is an open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of NCR300 injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCR300 injection | Experimental | Cohort1: Low dose NCR300 injection; Cohort2: Mid-low dose NCR300 injection; Cohort3: Mid-high dose NCR300 injection; Cohort4: High dose NCR300 injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCR300 injection | Biological | Subjects will receive at least 1 cycle of NCR300 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicity(DLT) | Number of participants with Dose-limiting toxicity in 28 days after first infusion | 4 weeks after initial infusion |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Time after doing at which maximun plasma concentration is reached(Tmax) |
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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 MRDï¼›
6.Have already recovered from the adverse reactions of previous treatmentï¼›
7.Having appropriate organ functionsï¼›
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaowen Gong | Contact | 15221195602 | xwgong@nuwacell.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhao Wang, Doctor | Capital Medical University | Principal Investigator |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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. |
| 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 |
| Minimal Residual Disease(MRD) | Changes in MRD before and after treatment | From the date of screening to a year after initial infusion |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |