NCT04327037

Safety of Expanded Haploidentical Natural Killer Cells for Leukemia

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology · Academic / Other
• Sex: All
• Age: 1 Year – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Acute Myeloid
• Leukemia, Acute Lymphoblastic

Interventions

Type	Name	Description
BIOLOGICAL	Expanded Haploidentical Natural Killer cells	One dose (from 20x to \>100x 10\^6 /kg) of expanded haploidentical NK cells
DRUG	IL-2	6 doses of IL-2 (1 × 10\^6 units/m2) from -1 day every other day.

Timeline

• Start date: 2019-01-02
• Primary completion: 2021-06-06
• Completion: 2021-06-30
• First posted: 2020-03-30
• Last updated: 2022-03-02

Locations

1 site across 1 country: Belarus