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

Plain Language Summary

Simplified for easier understanding

This study tests giving specially expanded natural killer (NK) cells — a type of immune cell — from a partially-matched family donor to children and young adults with hard-to-treat acute myeloid leukemia (AML). **You may be eligible if...** - You are a child or young adult with high-risk, relapsed, or refractory AML - Your performance score (Karnofsky or Lansky) is 70 or above - A partially-matched family member is available and willing to donate cells - You have provided written informed consent (or your guardian has) **You may NOT be eligible if...** - You have an active, uncontrolled infection - You have severe liver dysfunction - You test positive for HIV - The donor is pregnant, or tests positive for HIV, hepatitis B, or hepatitis C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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