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After cycle of chemotherapy patient receive one intravenous infusion of expanded haploidentical NK cells on day 0. On alternate days, 6 doses of subcutaneous IL-2 is administered with start on day -1.

One dose (from 20x to \>100x 10\^6 /kg) of expanded haploidentical NK cells

Expanded Haploidentical Natural Killer cells

6 doses of IL-2 (1 × 10\^6 units/m2) from -1 day every other day.

IL-2

Olga Aleinikova

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

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.

Safety of Expanded Haploidentical Natural Killer Cells for Leukemia

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

Adverse events will be graded according to the CTCAE v4.0

Analysis of donor chimerism at +2, 6, 10, 14, 21, 28 days after NK infusion.

Analysis of blast cells content in bone marrow by cytomorphology or detection of MRD level by flow/PCR before and after immunotherapy.

Days of platelets (\>50x10\^9/L) and leukocytes (\>1x10\^9/L) recovery.

Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) at +2, 6, 10, 14, 21, 28 days after NK infusion.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety of Expanded Haploidentical Natural Killer Cells for Leukemia	NCT04327037	Leukemia, Acute... Leukemia, Acute...	Expanded Haploi... IL-2	1 Year - 30 Years	Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Safety of Expanded Haploidentical Natural Killer Cells for Leukemia	NCT04327037	Leukemia, Acute... Leukemia, Acute...	Expanded Haploi... IL-2	1 Year - 30 Years	Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

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