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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05272293
• Other study ID #: haploNK_ HR/R/R_AML
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2021
• Est. completion date: June 2026

Study information

• Verified date: February 2023
• Source: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
• Contact: Tatsiana Shman, PhD
• Phone: +375296341853
• Email: shman[@]oncology.by
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 30 Years

Eligibility

Inclusion Criteria:

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 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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia

Intervention

Biological:
• NK cell infusions
Three doses of expanded haploidentical NK cells (30-100 x 10^6 cells /kg).

Locations

Country	Name	City	State
Belarus	Belarussian Research Center for Pediatric Oncology, Hematology and Immunology	Minsk	Minsk Region

Sponsors (1)

Lead Sponsor	Collaborator
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) (PR+ MLFS+CRi +CR)	The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), morphologic leukemia-free state (MLFS), and partial remission (PR) as measured by response criteria definitions for acute myeloid leukemia.	30 days after every a course of NK immunotherapy
Primary	Leukemia-free survival (LFS)	Time from achievement of CR/CRi/MLFS to the time of relapse, death in remission, or last follow-up.	1 year
Primary	Overall survival (OS)	The proportion of patients with overall survival	1 year
Secondary	Duration of persistence of infused NK cells	Days of persistence of donor NK cells	21 days after the first infusion
Secondary	Number of T, B, NK, activated T and NK cells after immunotherapy	Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) after NK infusions.	30 days after the first infusion