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
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The patient must not be eligible for standard of care therapy and have one of the following hematological malignancy:
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A confirmed MDS as defined by revised International Prognostic Scoring System criteria for intermediate, high-risk or very high-risk disease or MDS with Tumor Protein 53 mutation as detected by next-generation sequencing, after failure of prior treatment with at least 4 cycles of azacitidine or decitabine defined as:
- No response to treatment,
- Loss of response at any time point, or
- Intolerance to therapy.
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The patient must have evaluable disease as defined by: IWG 2006 Uniform Response Criteria for patients with MDS.
- 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