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RecruitingNCT07570407QiNKT-HSCTUpdated Aug 13, 2026

Quantification of Peripheral Blood iNKTs After Allogeneic Stem Cell Transplantation

An observational study in Allogeneic HSCT, Posttransplant Complications and GvHD, sponsored by University Hospital Pilsen. Recruiting at 1 site in Czechia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by University Hospital Pilsen · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
75
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The transplantation of allogeneic haematopoietic stem cells (HSCs) can lead to serious complications after transplantation, such as graft-versus-host disease (GvHD), infections and relapse due to immunosuppression. Invariant NKT cells (iNKT cells) play a pivotal role in modulating the immune response and have been demonstrated to be instrumental in the pathogenesis of GvHD, cytomegalovirus (CMV) infection, and relapse. Their levels are associated with the development of these complications. This multicentre study aims to test the feasibility of standardising iNKT cell monitoring and to investigate the association between iNKT cell levels and post-transplant complications.

Read the detailed description

Allogeneic haematopoietic stem cell transplantation (HSCT) is a treatment for many serious haematological malignancies. Despite advances in pre- and post-transplant management, a significant proportion of patients still develop adverse effects such as graft-versus-host disease (GvHD), relapse or cytomegalovirus reactivation. These reactions can significantly reduce patients' quality of life and may even be fatal. Invariant NKT cells (hereafter referred to as iNKT cells) are a rare population of T lymphocytes that play an important role in regulating the immune response. Depending on the expression of CD4 and CD8 markers, they can be divided into several subpopulations. iNKT cells can simultaneously support both Th1 and Th2 immune responses while suppressing the inflammatory response. Therefore, they appear to be suitable for treating diseases involving deregulated immunity, such as GvHD, autoimmune diseases, and oncological diseases. The concentration of iNKT cells after HSCT is highly variable. According to the available data, iNKT cell kinetics correspond to the severity of GvHD, as well as the risk of relapse and the development of infectious complications. However, these data are usually obtained using locally set protocols and come from single-centre measurements, which reduces their validity and clinical utility as both a biomarker and background data for possible allogeneic applications of iNKT cells in patients with low levels. To eliminate bias caused by specific local data processing and provide a robust dataset, a multicentre study is necessary to yield a representative set of results, as this is the only way to definitively establish the impact of iNKT cell levels on post-transplant outcomes. Flow cytometric analysis enables the combined examination of specific markers on the surface of cells and inside them. Due to the increasing complexity and heterogeneity of protocols, antibody manufacturers often resort to standardised dried panels, which ensure high consistency of measured data.

This project will involve monitoring iNKT cells at defined time points following allogeneic transplantation. The project's outcomes will be to determine the feasibility of standardising iNKT monitoring using the DryTube flow cytometry assay, establish differences in iNKT levels in transplanted patients across different centres, and estimate the association between iNKT levels and post-transplant complications.

02

Conditions studied

  • Allogeneic HSCT
  • Posttransplant Complications
  • GvHD
  • Relapse
  • Acute Myeloid Leukemia

Keywords

  • iNKT cells
  • HSCT
  • Flow cytometry
  • Reconsitution
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's planned enrollment of 75 is below the median of 200 across 702 observational studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

University Hospital Pilsen is the lead sponsor of 9 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who have undergone allogeneic hematopoietic cell transplantation and have been diagnosed with acute myeloid leukemia.

Inclusion criteria

  • Diagnosis: AML (exlusion of secondary disease)
  • Disease status at time of HSCT: complete remission
  • Karnofsky performance status: ≥80%
  • Source of HSC: PBSC

Exclusion criteria

Exclusion Criteria:

  • Prior transplant
  • Uncontrolled Malignancy
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • HSCT patients

    Patients who have undergone allogeneic hematopoietic cell transplantation and have been diagnosed with acute myeloid leukemia.

    Diagnostic Test: blood draw

Interventions

  • Diagnostic testblood draw

    Blood draw for diagnostic test

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What researchers measure

Primary outcomes

  1. Detection of peripheral blood iNKTs after HSCT using flow cytometry

    iNKTs will be monitored in peripheral blood using a mixture of dried antibodies and bulk lysis and flow cytometry. This mixture of antibodies contains the specific iNKT marker (TCRVα24Jα18) and markers for the main subsets. The percentage of iNKT cells among leukocytes and T cells, as well as the proportion of CD4 and CD8 iNKT subsets, will be provided.

    Time frame: Day 30, day 60, day 90

Secondary outcomes

  1. Absolute Number of Circulating iNKT Cells and Their Dynamics After HSCT

    Leukocyte count will be estimated through hematological analysis, and circulating iNKTs will be counted based on flow cytometry percentage in Patient´s Peripheral Blood At day + 30, +60, +90 After HSCT. The level of iNKTs will be reported as the number of cells per milliliter of peripheral blood.

    Time frame: Day 30, day 60, day 90

Other outcomes

  1. Correlation of iNKT cell levels with Post-transplant Complications

    Correlation of iNKT cell levels with Post-transplant Complications

    Time frame: Day 30, day 60, day 90

07

Study locations

1 of 1 sites recruiting
  • University Hospital Pilsen
    Pilsen, Czechia 32300, Czechia
    • Monika Holubová, MSc. · Contact · holubovam@fnplzen.cz · +420 377 103 991
    • Lenka Lukášová, MD, MSc. · Contact · LUKASOVALE@fnplzen.cz · +420 377 103 871
    • Michal Karas, MD, MSc. · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07570407
Lead sponsor
University Hospital Pilsen
Responsible party
Sponsor
First posted
May 6, 2026
Start date
Aug 1, 2026
Primary completion
Dec 31, 2028 (estimated)
Completion
Jan 31, 2029 (estimated)
Last update
Aug 13, 2026

Study contacts

Monika Holubová, MSc.
Contact
holubovam@fnplzen.cz
+420 377 103 991
Lenka Lukášová, MD, MSc.
Contact
LUKASOVALE@fnplzen.cz
+420 377 103 871

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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