NCT04327037

Brief Summary

The purpose of this study is to estimate the safety of ex vivo expanded haploidentical natural killer (NK) cells for patients with leukemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2021

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

2.4 years

First QC Date

March 18, 2020

Last Update Submit

February 28, 2022

Conditions

Leukemia, Acute MyeloidLeukemia, Acute Lymphoblastic

Keywords

ImmunotherapyNatural killer cells

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events

    Adverse events will be graded according to the CTCAE v4.0

    1 months

Secondary Outcomes (4)

  • Days of persistence of adoptively-transferred haploidentical NK cells

    1 months

  • Occurrence of disease response

    1 months post infusion

  • Median time to leukocytes and platelets recovery

    2 months post infusion

  • Number of T, B, NK, activated T and NK cells after immunotherapy

    1 months post infusion

Study Arms (1)

NK cells + IL-2

EXPERIMENTAL

After cycle of chemotherapy patient receive one intravenous infusion of expanded haploidentical NK cells on day 0. On alternate days, 6 doses of subcutaneous IL-2 is administered with start on day -1.

Biological: Expanded Haploidentical Natural Killer cellsDrug: IL-2

Interventions

Expanded Haploidentical Natural Killer cellsBIOLOGICAL

One dose (from 20x to \>100x 10\^6 /kg) of expanded haploidentical NK cells

NK cells + IL-2
IL-2DRUG

6 doses of IL-2 (1 Ă— 10\^6 units/m2) from -1 day every other day.

Also known as: Ronkoleukinum
NK cells + IL-2

Eligibility Criteria

Age1 Year - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients:
  • Relapsed acute myeloid or lymphoblastic leukemia
  • Primary refractory myeloid or lymphoblastic leukemia
  • Karnofsky or Lansky performance scale greater or equal to 70
  • Written informed consent
  • Donor:
  • Haploidentical family donor
  • \> 18 years old
  • Donor suitable for cell donation and apheresis according to standard criteria
  • Written informed consent

You may not qualify if:

  • 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 or breast feeding
  • Positive serology for HIV, hepatitis B or C.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Minsk, Minsk Oblast, 223053, Belarus

Location

Related Publications (1)

  • Shman TV, Vashkevich KP, Migas AA, Matveyenka MA, Lasiukov YA, Mukhametshyna NS, Horbach KI, Aleinikova OV. Phenotypic and functional characterisation of locally produced natural killer cells ex vivo expanded with the K562-41BBL-mbIL21 cell line. Clin Exp Med. 2023 Oct;23(6):2551-2560. doi: 10.1007/s10238-022-00974-2. Epub 2022 Dec 17.

    PMID: 36527513DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • Olga Aleinikova

    Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2020

First Posted

March 30, 2020

Study Start

January 2, 2019

Primary Completion

June 6, 2021

Study Completion

June 30, 2021

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

BE(1)