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

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Biological: Expanded haploidentical NK cells

Study type: Interventional

Funder types: Other

Identifiers

NCT05334693

HaploNK_consolidation_AML

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 6 months to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Expanded haploidentical NK cell immunotherapy

Experimental group

Description:

After a lymphodepleting chemotherapy a patient receive two intravenous infusions of expanded haploidentical NK cells.

Treatment:

Biological: Expanded haploidentical NK cells