Natural Killer Cells Infusion for Treating Acute Myeloid Leukemia Patients With Minimal Residual Disease

Study Overview
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Brief Summary
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This trial will evaluate the effectiveness and safety of haploid donor-derived in vitro activated natural killer(NK) cells infusion for Treating acute myeloid leukemia Patients With minimal residual disease.

Detailed Description
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Patients of acute myeloid leukemia after chemotherapy with MRD(minimal residual disease) will receive NK cell infusion combined with consolidation chemotherapy. The bone marrow morphology and MRD remission of the patients will be observed 15 days after the same treatment. All patients will be followed up for 1 year. NK cells are prepared in Beijing iCELL Biotechnology Co.,Ltd, which is subsidiary to Shanghai iCELL Biotechnology Co.,Ltd.

Official Title
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Phase I Clinical Trial of Haploid Donor-derived in Vitro Activated Natural Killer Cells Infusion for Patients With Minimal Residual Disease After Consolidation Therapy for Acute Myeloid Leukemia

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Biological: haploid allogeneic NK cell therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with acute myeloid leukemia; MRD after 2 course of standard chemotherapy; No plan for hematopoietic stem cell transplantation; Hemoglobin (Hb) >=60g/L, white blood cell count (WBC) >=2.5x10^9/L, platelet count >=30x10^9/L; Patients have self-knowledge ability and can sign informed and voluntary consent forms; Patients or their clients, guardians of pediatric patients signed the informed and voluntary consent form and joined the study. Exclusion Criteria: Intracranial hypertension or unconsciousness; Symptomatic heart failure or severe arrhythmia; Respiratory failure; With other types of malignant tumor diseases; T lymphocytic acute leukemia; Diffuse intravascular; Serum creatinine and / or urea nitrogen >=1.5 times the normal value;coagulation; Serum total bilirubin >=1.5 times the normal value; Sepsis or other difficult-to-control infections; Uncontrollable diabetes; severe mental disorders; WHO physical status classification >=3; People who are allergic to Interleukin-2; Patients after organ transplant; Pregnant and lactating women.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: haploid allogeneic NK cell therapy with chemotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: haploid allogeneic NK cell therapy<br>haploid allogeneic NK cell therapy with chemotherapy | Biological: haploid allogeneic NK cell therapy<br>* NK cells will be intravenously infused to the patient for 2 days, with following subcutaneously injection of Interleukin-2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Residual Disease (MRD) | MRD-negative is defined as <0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as >=0.1% blasts with leukemia-associated phenotype detected by flow cytometry. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Evaluation of toxicities defined as any CTCAE (v. 4.03) | 12 months |