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
Celyad Oncology SA
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.
Description
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 infus…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria (main): * The patient must not be eligible for standard of care therapy and have one of the following hematological malignancy: 1. 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 rem…
Interventions
- BiologicalCYAD-02
CYAD-02 is a Chimeric Antigen Receptor-T (CAR-T) administered after CYFLU.
- DrugENDOXAN
administered as preconditioning chemotherapy
- DrugFludara
administered as preconditioning chemotherapy
Locations (5)
- Mayo Clinic Cancer CenterJacksonville, Florida
- University of Kansas Cancer CenterFairway, Kansas
- Uz LeuvenLeuven
- Chu LiegeLiège
- AZ DELTARoeselare