Safety of Expanded Haploidentical Natural Killer Cells for Leukemia

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Acute Disease
Leukemia
Leukemia, Acute Lymphoblastic
Leukemia, Acute Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Clinical Trial Details

NCT number	NCT04327037
Study type	Interventional
Source	Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Contact
Status	Completed
Phase	Phase 1
Start date	January 2, 2019
Completion date	June 30, 2021

View Details

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