RecruitingPhase 1Phase 2NCT05272293

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

Sponsor

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Enrollment

15 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

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.

Eligibility

Min Age: 6 MonthsMax Age: 30 Years

Inclusion Criteria10

Patients:
primary high risk AML
primary refractory AML
relapsed AML
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 Criteria7

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

Interventions

BIOLOGICALNK cell infusions

Three doses of expanded haploidentical NK cells (30-100 x 10\^6 cells /kg).

Locations(1)

Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Minsk, Minsk Oblast, Belarus

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NCT05272293

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