Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02

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.

Trial Details

NCT ID
NCT04167696
Phase
PHASE1
Sponsor
Celyad Oncology SA
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • CYAD-02
  • ENDOXAN
  • Fludara
Locations (sample)
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Fairway, Kansas, United States|39.02223,-94.6319
  • Leuven, Belgium|50.87959,4.70093
  • Liège, Belgium|50.63373,5.56749
  • Roeselare, Belgium|50.94653,3.12269

Key Eligibility Criteria

  • The patient must not be eligible for standard of care therapy and have one of the following hematological malignancy:
  • A confirmed relapsed or refractory acute AML (i.e. ≥ 5% blasts in bone marrow or in peripheral blood) with revised European LeukemiaNet (ELN) 2017 …
  • 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

For full eligibility, visit ClinicalTrials.gov.

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