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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04327037
Other study ID # BelarusianPediatric_NK_Pilot
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2, 2019
Est. completion date June 30, 2021

Study information

Verified date February 2022
Source Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Immunotherapy with natural killer (NK) cells may improve the results of treatment for patients with cancer. However, for better efficiency high doses of NK cells are required. For this purpose, NK cells were expanded in the presence of feeder K562 cells gene-modified for expression 4-1BBL and membrane bound IL-21. In the result of expansion, large number of activated NK cells are obtained. Protocol of immunotherapy includes conditioning (fludarabine + cyclophosphamide or any other protocol of chemotherapy) followed by expanded NK cells intravenous infusion. To sustain proliferation of donor NK cells in vivo patients receive 6 doses of Il-2 every second day. 10 patients will be enrolled in phase I to test different doses of NK cells: 20, 50, 70, 100 and >100 x 10^6/kg.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 30, 2021
Est. primary completion date June 6, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Year to 30 Years
Eligibility Inclusion Criteria: 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 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 or breast feeding - Positive serology for HIV, hepatitis B or C.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Expanded Haploidentical Natural Killer cells
One dose (from 20x to >100x 10^6 /kg) of expanded haploidentical NK cells
Drug:
IL-2
6 doses of IL-2 (1 × 10^6 units/m2) from -1 day every other day.

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 Incidence of Treatment-Emergent Adverse Events Adverse events will be graded according to the CTCAE v4.0 1 months
Secondary Days of persistence of adoptively-transferred haploidentical NK cells Analysis of donor chimerism at +2, 6, 10, 14, 21, 28 days after NK infusion. 1 months
Secondary Occurrence of disease response Analysis of blast cells content in bone marrow by cytomorphology or detection of MRD level by flow/PCR before and after immunotherapy. 1 months post infusion
Secondary Median time to leukocytes and platelets recovery Days of platelets (>50x10^9/L) and leukocytes (>1x10^9/L) recovery. 2 months post 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) at +2, 6, 10, 14, 21, 28 days after NK infusion. 1 months post infusion
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