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Allogeneic Hematopoietic Stem Cell (HSC) TransplantationExpiNKT1NCT03605953

Expansion of Invariant NKT Cells for a Cell Immunotherapeutic Approach Allowing the Control of Graft Versus Host-disease and Preserving the Graft Versus Leukemia Effect After Allogeneic Hematopoietic Stem Cell Transplantation

An observational study of Allogeneic Hematopoietic Stem Cell (HSC) Transplantation, run by Central Hospital, Nancy, France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Allogeneic hematopoietic stem cell (HSC) transplantation remains the most efficient cellular immunotherapeutic approach for the treatment of myeloid hematological malignancies. However, its use is hampered by the risk of developing acute graft-versus-host disease (aGVHD). Read more about this study

Who is it for?
Ages 18 years and older
How many people
134 participants
Where
No sites listed yet
Study dates
1 Oct 2018to 1 Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: healthy donors of HSCT

Who may be able to join

  • Hematopoietic stem cells :
  • from major donors after mobilization by G-CSF, informed of the research and not having opposed it
  • Collected after verification by the cell therapy centre of the presence of a sufficient quantity of CSH for transplantation

Who cannot join

  • Hematopoietic stem cells (HSCs) from donors seropositive for HIV, HCV, HTLV1 and HBV (except post-vaccination profile)

Trial locations and contacts

No sites are listed yet.

Marie-Thérèse RUBIO, PU-PH contact

0383153282 ext. +33

m.rubio@chru-nancy.fr

About this study

Allogeneic hematopoietic stem cell (HSC) transplantation remains the most efficient cellular immunotherapeutic approach for the treatment of myeloid hematological malignancies. However, its use is hampered by the risk of developing acute graft-versus-host disease (aGVHD). Invariant NKT cells (iNKT) represent a good candidate of immuno-regulatory cells that could control GVHD while preserving the anti-leukemic effect (GVL) of HSCT. Our team have shown that higher numbers and expansion capacity of CD4- iNKT cells contained in the HSC graft were associated with reduced risk of aGVHD but preserved GVL effect and that some healthy donors have low numbers and expansion capacity CD4- iNKT cells 1.

The objective of this project is to develop a strategy allowing to expand human CD4- iNKT cells from healthy donors of HSC grafts that would be transposable to GMP-validated cell production. Our team proposes to first determine the best strategy to expand the CD4- iNKT cell subset from G-SCF mobilized peripheral blood stem cells (PBSC) obtained from healthy donors, at little scale using cultures GMP validated conditions, by comparing the convention expansion protocol using IL-2 alone to IL-7, IL-15, IL-4 or combination of those cytokines involved in the expansion of T cells and by culturing the cells in a bioreactor. Our team will then explore the characteristics of cells after expansion in terms of phenotype, transcription signature and functions in vitro (in mixed lymphocyte reaction) and in vivo in a well-established xenogeneic model of GVHD.

Keywords
Cell therapy, immuno-modulation, immunotherapy, Hematology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kinetic of iNKT cells (flask culture)

    Measured: from day 0 to day 14

  2. time of culture to reach the maximal expansion factor

    Measured: day 14

  3. Percentage of cells alive

    Measured: day 14

  4. Percentages of CD4- iNKT cells capable of producing IFN-γ after expansion

    Measured: day 14

Secondary outcomes (11)

  1. Kinetic of iNKT cells(culture in bioreactor system)

    Measured: From day 0 to day 14

  2. Expression of cytokine receptors CD4- iNKT data

    Measured: day 14

  3. Expression of cytokine receptors CD4+ iNKT data

    Measured: day 14

  4. transcriptional pattern CD4- iNKT data

    Measured: day 14

  5. Transcriptional pattern CD4+ iNKT

    Measured: day 14

  6. Percentage of recovery of CD4- iNKT cells after immunomagnetic selection

    Measured: day 14

  7. Proportion of Th1 producing T cells stimulated by allogeneic dendritic cells

    Measured: day 6 in a mixed lymphocyte reaction

  8. Proportion of Th17 producing T cells stimulated by allogeneic dendritic cells

    Measured: day 6 in a mixed lymphocyte reaction

  9. Proportion of mice protected from GVHD mortality in a xeno-GVHD mouse model

    Measured: survival proportions between day 28 and day 60 post-transplantation

  10. Ratio of iNKT/T cells to control xeno-GVHD mortality

    Measured: survival proportions between day 28 and day 60 post-transplantation

  11. Proportion of mice protected from leukemia development

    Measured: survival proportions between day 28 and day 60 post-transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2018
  2. Study start1 Oct 2018 (estimated)
  3. Primary completion1 Oct 2019 (estimated)
  4. Study completion1 Apr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03605953
Sponsor's protocol ID
PRTK2017/ExpiNKT-RUBIO/VS
Acronym
ExpiNKT1
Status last verified
Jul 2018
First submitted
21 Jul 2018
Last updated
30 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • O'Neal J, Mavers M, Jayasinghe RG, DiPersio JF. Traversing the bench to bedside journey for iNKT cell therapies. Front Immunol. 2024 Aug 7;15:1436968. doi: 10.3389/fimmu.2024.1436968. eCollection 2024.

    PubMed 39170618

Questions about this trial

What is this clinical trial studying?

An observational study of Allogeneic Hematopoietic Stem Cell (HSC) Transplantation, run by Central Hospital, Nancy, France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marie-Thérèse RUBIO, PU-PH (0383153282 ext. +33, m.rubio@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kinetic of iNKT cells (flask culture) (time frame: from day 0 to day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03605953, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.

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