NCT04167696

Open-label, Phase I, Multi-center Study to Determine in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients the Recommended Dose of CYAD-02 After a Non-myeloablative Preconditioning Chemotherapy Followed by a Potential Consolidation Cycle

Study Summary

An open-label, phase I, multi-center study to determine in relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-02 consolidation cycle for non-progressive patient. A maximum of 27 r/r AML/MDS patients will be evaluated in this study in case of no dose limiting toxicity (DLT) and no replacement of patients.

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Interventions

CYAD-02BIOLOGICAL
CYAD-02 is a Chimeric Antigen Receptor-T (CAR-T) administered after CYFLU.
ENDOXANDRUG
administered as preconditioning chemotherapy
FludaraDRUG
administered as preconditioning chemotherapy

Study Locations

FacilityCityStateCountry
Mayo Clinic Cancer CenterJacksonvilleFloridaUnited States
University of Kansas Cancer CenterFairwayKansasUnited States
Uz LeuvenLeuvenBelgium
Chu LiegeLiègeBelgium
AZ DELTARoeselareBelgium

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026