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Study of an Innovative Therapy Using CAR-T Cells Targeting IL-1RAP in Patients With High-Risk Myelodysplastic Syndromes (MDS

NCT07455500 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-06

No results posted yet for this study

Summary

The surface protein IL-1RAP, expressed by leukemic blast cells, represents a target of interest for patients with acute myeloid leukemia (AML).

Its restricted and specific expression on leukemic cells makes it a promising target for chimeric antigen receptor T-cell (CAR-T cell) immunotherapy.

High-risk myelodysplastic syndromes (MDS) correspond to a pre-leukemic condition characterized by an accumulation of bone marrow blasts. Unfortunately, very few effective treatments are currently available, apart from allogeneic hematopoietic stem cell transplantation, which can only be performed in a limited number of patients. It has been demonstrated that high-risk MDS blasts express IL-1RAP.

The project will aim to:

* Confirm IL-1RAP expression on primary MDS blast cells.
* Measure circulating soluble IL-1RAP in plasma samples from MDS patients.
* Investigate the interaction with the microenvironment in relation to IL-1RAP cellular expression.
* Evaluate the effect of first-line standard treatment for MDS on IL-1RAP surface expression.
* Assess the in vitro efficacy of an IL-1RAP-targeted CAR-T cell on MDS leukemic stem cells.
* Assess the in vivo efficacy of an IL-1RAP-targeted CAR-T cell in a humanized murine model of MDS.

To successfully conduct this project, it is essential to collect blood and bone marrow samples from high-risk MDS patients

This project will require the collection of bone marrow and blood samples from patients with MDS, either newly diagnosed or currently undergoing treatment.

Conditions

Interventions

OTHER

Bone marrow and blood sampling

Patients diagnosed with, or suspected of having, low-risk or high-risk myelodysplastic syndrome (MDS) will undergo bone marrow aspirate and peripheral blood sample collection at the time of initial diagnostic evaluation. These procedures will be performed exclusively within the context of routine clinical care, without any additional invasive procedures specifically for research purposes. For patients with high-risk MDS, additional bone marrow and peripheral blood samples may be collected in the event of suspected relapse during active treatment or following allogeneic hematopoietic stem cell transplantation, in accordance with standard-of-care clinical assessments

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Mathieu Meunier, MD, PhD · CHU Grenoble Alpes

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2030-01-31
Completion
2031-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07455500 on ClinicalTrials.gov