Natural killer (NK) cells exert antitumor effects via their cytotoxic and cytokine-secreting capacity without present of clinical symptoms. In recent years, with the continuous advancement of in vitro expansion methods, the application of good quality management technology, NK cells could be clinical grade expanded without the need for pre-purification, feeder-free, and serum-free culture. In this clinical trial the investigators want to demonstrate the safety and efficacy chemotherapy combined with donor-derived in vitro activated NK cells infusion for high risk AML patients.
Despite improvements in new drugs and allogeneic stem cell transplantation (allo-SCT), relapse remains a problem for patients with acute myeloid leukemia (AML). Natural killer (NK) cells exert antitumor effects via their cytotoxic and cytokine-secreting capacity without present of clinical symptoms. In recent years, with the continuous advancement of in vitro expansion methods, the application of good quality management technology (GMP technology), NK cells could be clinical grade expanded without the need for pre-purification, feeder-free, and serum-free culture. Preclinical studies have confirmed that adoptive infusion expanded and activated NK cells can specifically recognize and kill tumor cells in mice without causing GVHD, which is a safe and effective treatment. Therefore, in this clinical trial the investigators want to enroll patients with acute AML (excluding APL) who are continued to be unresolved, or relapsed after remission, or continued to be MRD-positive after induction and consolidation according to NCCN standard chemotherapy regimen. Chemotherapy was combined with donor-derived in vitro activated NK cells infusion to evaluate the safety and effectiveness effect of NK cells and to explore the dynamics of NK in vivo after adoptive infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
chemotherapy combined with NK cells infusion
Peking University Institute of Hematology
Beijing, Beijing Municipality, China
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Closely monitor the patient's temperature, rash, BP, and other adverse reactions during the 48 hours after the infusion, and pay attention to acute and chronic GVHD; follow up once every 1-2 weeks within 6 months after the infusion, and review the blood count and biochemistry. Increase or decrease the relevant inspections and inspection frequencies as appropriate according to the condition;
Time frame: Two months after NK treatment
Number of participants acheived CR post NK treatment
To evaluate the CR rate 1 month after NK treatment
Time frame: One month after NK treatment
Monitor the metabolism, migration and reconstruction of NK cells in vivo post NK treatment
The number of NK cells were evaluated before and after the completion of the infusion.
Time frame: One month after NK treatment
Assess the cell count recovery time of peripheral blood in chemotherapy combined with NK infusion
The blood count were evaluated closely before and after the completion of the infusion.
Time frame: Two months after NK treatment
Number of participants relapsed post NK treatment
To evaluate the bone marrow status every months after NK treatment
Time frame: Every months after NK treatment within 1 year
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