NCT05272293

Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With AML

Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With High-risk, Refractory or Relapsed AML

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology · Academic / Other
• Sex: All
• Age: 6 Months – 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells for children/young adults with primary high risk or refractory AML and relapsed AML.

Detailed description

Immunotherapy with NK cells may improve the treatment results in AML. For better efficiency high cell doses or several infusions of NK cells are required. For this purpose, donor NK cells are expanded in the presence of feeder K562-mbIL21-41BBL cell line. For patients with high-risk primary AML a cycle of immunotherapy includes chemotherapy (HD-ARA-C+IDA) followed by three doses of NK cells infusion. For patients with refractory/relapsed AML a cycle of immunotherapy includes chemotherapy (FLAG - fludarabine, cytarabine, G-CSF) followed by three doses of NK cells infusion. A 2nd cycle of therapy may be administered if a recipient continues to meet the eligibility criteria.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	NK cell infusions	Three doses of expanded haploidentical NK cells (30-100 x 10\^6 cells /kg).

Timeline

• Start date: 2021-11-01
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2022-03-09
• Last updated: 2024-08-28

Locations

1 site across 1 country: Belarus