Spots Global Cancer Trial Database for Safety of Expanded Haploidentical Natural Killer Cells for Leukemia

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Trial Identification

Brief Title: Safety of Expanded Haploidentical Natural Killer Cells for Leukemia

Official Title: Pilot Study of Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Leukemia

Study ID: NCT04327037

Conditions

Leukemia, Acute Myeloid

Leukemia, Acute Lymphoblastic

Interventions

Expanded Haploidentical Natural Killer cells

IL-2

Study Description

Brief Summary: The purpose of this study is to estimate the safety of ex vivo expanded haploidentical natural killer (NK) cells for patients with leukemia.

Detailed Description: Immunotherapy with natural killer (NK) cells may improve the results of treatment for patients with cancer. However, for better efficiency high doses of NK cells are required. For this purpose, NK cells were expanded in the presence of feeder K562 cells gene-modified for expression 4-1BBL and membrane bound IL-21. In the result of expansion, large number of activated NK cells are obtained. Protocol of immunotherapy includes conditioning (fludarabine + cyclophosphamide or any other protocol of chemotherapy) followed by expanded NK cells intravenous infusion. To sustain proliferation of donor NK cells in vivo patients receive 6 doses of Il-2 every second day. 10 patients will be enrolled in phase I to test different doses of NK cells: 20, 50, 70, 100 and \>100 x 10\^6/kg.