Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML

Phase 1

Recruiting

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT05334693
• Lead Sponsor: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Brief Summary

The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells as consolidation therapy for children/young adults with intermediate risk 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. The cycle of immunotherapy includes chemotherapy (cyclophosphamide, fludarabine) followed by two doses of NK cells infusion.

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Patients:

• primary intermediate risk AML in molecular complete remission;
• primary high risk AML in molecular complete remission awaiting unrelated HSCT;
• Karnofsky or Lansky performance scale greater or equal to 70;
• written informed consent.

Donors:

• haploidentical family donor;
• donor suitable for cell donation and apheresis according to standard criteria;
• written informed consent.

Exclusion Criteria

Patients:

• uncontrolled infection;
• severe hepatic dysfunction: SGOT or SCPT >=5x upper limit of normal for age;
• positive serology for human immunodeficiency virus (HIV).

Donors:

• pregnancy;
• positive serology for HIV, hepatitis B or C.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Relapse-free survival (RFS)	2 years	Time from achievement of CR to the time of relapse or death from any cause.
Overall survival (OS)	2 years	The proportion of patients with overall survival

Secondary Outcome Measures

Name	Time	Method
Persistence of donor NK cells	21 days after the first infusion	Days of persistence of donor NK cells
Number of T, B, NK, activated T and NK cells after immunotherapy	28 days after the first infusion	Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) after NK infusions.

Trial Locations

Locations (1)

Belarussian Research Center for Pediatric Oncology, Hematology and Immunology; 🇧🇾 Minsk, Minsk Region, Belarus