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.
A confirmed relapsed or refractory acute AML (i.e. ≥ 5% blasts in bone marrow or in peripheral blood) with revised European LeukemiaNet (ELN) 2017 risk stratification for favorable, intermediate or adverse groups, after at least one prior therapy defined as either
Recurrence of disease after a first complete remission and not eligible for a second course of induction therapy, or
Recurrence of disease after a second complete remission, or
Failure to achieve a Complete Response after induction chemotherapy.
Patients with a confirmed or history of tumor involvement in the central nervous system
Patients who have received any cancer therapy with therapeutic intent (investigational agent or not)
Patients with any positive serology test results at baseline
Patients who plan to receive, are concurrently receiving or have received any investigational agent within 3 weeks before the planned day for the first CYAD-02 infusion
Sequential
CYAD-02
Biological/VaccineCYAD-02 is a Chimeric Antigen Receptor-T (CAR-T) administered after CYFLU.
ENDOXAN
Drugadministered as preconditioning chemotherapy
Fludara
Drugadministered as preconditioning chemotherapy
Occurrence of Dose Limiting Toxicities as defined per protocol in order to define the final recommended dose.
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