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This trial will explore the maximum tolerated dose(MTD)of NKG2D CAR-NK cells in the treatment of relapsed or/and refractory AML in a dose-escalation manner, and observe the clinical safety and efficacy.
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Inclusion criteria
Age: ≥ 3 years old and ≤ 75 years old, male or female;
Meet the diagnostic criteria for recurrent AML specified in the guidelines for diagnosis and treatment of acute myelogenous leukemia (relapse/refractory) in China (2017): leukemic cells reappear in peripheral blood or bone marrow MRD > 0.1% after complete remission (CR), including relapse after allogeneic hematopoietic stem cell transplantation or extramedullary leukemic cell infiltration.
Meet the diagnostic criteria for refractory AML specified in the guidelines for diagnosis and treatment of acute myelogenous leukemia (relapse/refractory) in China (2017): Initial cases with failure of 2 lines of standard treatment; patients who relapsed within 12 months after consolidation intensification after CR; recurrence in 12 months and no respond to conventional chemotherapy; 2 or more recurrences; persistent extramedullarial leukemia;
Patients currently have no effective treatment options, such as chemotherapy or allogeneic hematopoietic stem cell transplantation, or patients voluntarily choose to infuse NKG2D CAR-NK cells as the first treatment option;
Physical status assessment (ECOG-PS) of the Eastern Oncology Collaborative Group is 0-2 points;
Life expectancy ≥ 12 weeks from the time of enrollment;
The main organs of the patient are well functioned: (1) cardiac function: no heart disease or coronary heart disease, the patient's cardiac function grade 1-2; (2) liver function: TBIL≦3ULN, AST≦2.5ULN, ALT≦2.5ULN; (3) Renal function: Cr≦1.25ULN;
Flow cytometry check for NKG2D ligand expression on the surface of cancer cells as a reference for patient selection;
The patient's peripheral superficial vein is accessible for IV insertion and blood draws;
No other serious diseases that conflict with this protocol (e.g., autoimmune diseases, immunodeficiency, organ transplantation);
No history of other malignant tumors;12. Women of childbearing age must be tested negative for pregnancy within 7 days, and subjects of childbearing age must use appropriate contraception during both the trial and for 3 months after the test;
Subjects have negative HIV, HBV, HCV, syphilis serology test results; 14. Written informed consent form must be signed by the patient or the patient's immediate family members before enrollment.
Exclusion criteria
Primary purpose
Allocation
Interventional model
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30 participants in 1 patient group
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Central trial contact
Hu YongXian
Data sourced from clinicaltrials.gov
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