drugset
drugset / Trial / NCT04167696

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

NCT04167696 ↗

Phase 1 Recruiting 27 enrolled Celyad Oncology SA
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2019-11-25
Primary completion
2021-12
Completion
2035-02

Drugs

EvaluationDrugModalityDoseRoute
Subject CYAD-02 Cell therapy 1e+08 unknown —
Subject CYAD-02 Cell therapy 3e+08 unknown —
Subject CYAD-02 Cell therapy 1e+09 unknown —
Background Cyclophosphamide Other / unclassified 300 mg/m2 —
Background Fludarabine Small molecule 30 mg/m2 —

Indications

acute myeloid leukemia myelodysplastic syndrome