Natural Killer Cells Infusion for Treating Acute Myeloid Leukemia Patients With Minimal Residual Disease
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|ClinicalTrials.gov Identifier: NCT04209712|
Recruitment Status : Not yet recruiting
First Posted : December 24, 2019
Last Update Posted : December 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Biological: haploid allogeneic NK cell therapy||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||haploid allogeneic NK cell therapy with chemotherapy|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: haploid allogeneic NK cell therapy
haploid allogeneic NK cell therapy with chemotherapy
Biological: haploid allogeneic NK cell therapy
NK cells will be intravenously infused to the patient for 2 days, with following subcutaneously injection of Interleukin-2.
- Minimal Residual Disease (MRD) [ Time Frame: 12 months ]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.
- Number of participants with adverse events [ Time Frame: 12 months ]Evaluation of toxicities defined as any CTCAE (v. 4.03)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209712
|Contact: Jiang ZHUemail@example.com|
|Principal Investigator:||Xian Zhang||Hebei Yanda Ludaopei Hospital|