CYAD-02-001 (R/R) CYCLE-1

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 treatments

Dose escalation of  CYAD-02 (Chimeric Antigen Receptor-T (CAR-T)) administered after cyclophoshamide and fludarabine

Inclusion criteria

• 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 remission, or
     • Failure to achieve a Complete Response after induction chemotherapy.

• The patient must have evaluable disease as defined by: Revised Recommendations of the International Working Group (IWG) for Diagnosis, Standardization of Response Criteria for AML patients,

• The absolute peripheral blast count should be < 15,000/L.

Exclusion criteria

• 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)

Participating sites 

• University Hospital Leuven Gasthuisberg
• AZ Delta
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