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.
This open-label phase I, multi-center study aims 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 CYAD-02 consolidation cycle for non-progressive patients. During dose escalation, three prespecified dose-levels of CYAD-02 will be evaluated in three cohorts. Patient enrollment during dose-escalation will be staggered according to the Fibonacci 3+3 design and extension of cohorts II and III will be done in parallel. The first CYAD-02 infusion will be administered after prior non-myeloablative preconditioning chemotherapy (CYFLU) administered on three consecutive days. Non-progressive patients meeting the criteria specified below may receive a consolidation cycle with three additional CYAD-02 infusions at a 2-week interval without prior preconditioning. For all patients who received at least one CYAD-02 infusion, the overall study duration will be approximately 15 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Mayo Clinic Cancer Center
Jacksonville, Florida, United States
NOT_YET_RECRUITINGUniversity of Kansas Cancer Center
Fairway, Kansas, United States
RECRUITINGUz Leuven
Leuven, Belgium
RECRUITINGChu Liege
Liège, Belgium
RECRUITINGAZ DELTA
Roeselare, Belgium
RECRUITINGOccurrence of Dose Limiting Toxicities as defined per protocol in order to define the final recommended dose.
Time frame: from start the first infusion of CYAD-02 (Day1) up to Day36.
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