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

Sponsor

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology (Other)

Overall Status

Recruiting

CT.gov ID

NCT05272293

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Biological: NK cell infusions	Phase 1/Phase 2

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: expanded haploidentical NK cell immunotherapy After a cycle of chemotherapy a patient receive three intravenous infusions of expanded haploidentical NK cells.	Biological: NK cell infusions Three doses of expanded haploidentical NK cells (30-100 x 10^6 cells /kg).

Arm

Intervention/Treatment

Experimental: expanded haploidentical NK cell immunotherapy

After a cycle of chemotherapy a patient receive three intravenous infusions of expanded haploidentical NK cells.

Biological: NK cell infusions

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

Outcome Measures

Primary Outcome Measures

Objective Response Rate (ORR) (PR+ MLFS+CRi +CR) [30 days after every a course of NK immunotherapy]
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.
Leukemia-free survival (LFS) [1 year]
Time from achievement of CR/CRi/MLFS to the time of relapse, death in remission, or last follow-up.
Overall survival (OS) [1 year]
The proportion of patients with overall survival

Secondary Outcome Measures

Persistence of infused 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 [30 days after the first infusion]
Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) after NK infusions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Belarussian Research Center for Pediatric Oncology, Hematology and Immunology	Minsk	Minsk Region	Belarus	223053

Sponsors and Collaborators

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Investigators

Principal Investigator: Olga Aleinikova, MD, Prof, Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

ClinicalTrials.gov Identifier:

NCT05272293

Other Study ID Numbers:

haploNK_ HR/R/R_AML

First Posted:

Mar 9, 2022

Last Update Posted:

Mar 9, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Natural killer cells, immunotherapy

Study Results

No Results Posted as of Mar 9, 2022