OncoMatch/Clinical Trials/NCT04167696
Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02
Is NCT04167696 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including CYAD-02 and ENDOXAN for acute myeloid leukemia.
Treatment: CYAD-02 · ENDOXAN · Fludara — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Allowed: TP53 mutation
Prior therapy
Must have received: chemotherapy — AML: at least one prior therapy
after at least one prior therapy
Must have received: hypomethylating agent (azacitidine, decitabine) — MDS: at least 4 cycles
after failure of prior treatment with at least 4 cycles of azacitidine or decitabine
Cannot have received: any cancer therapy with therapeutic intent
Patients who have received any cancer therapy with therapeutic intent (investigational agent or not)
Cannot have received: investigational agent
Exception: if received within 3 weeks before the planned day for the first CYAD-02 infusion
Patients who plan to receive, are concurrently receiving or have received any investigational agent within 3 weeks before the planned day for the first CYAD-02 infusion
Lab requirements
Kidney function
adequate renal function as assessed by standard laboratory criteria
Liver function
adequate hepatic function as assessed by standard laboratory criteria
Cardiac function
left ventricular ejection fraction of ≥ 40 %, as determined by echocardiography or a multigated acquisition scan
adequate hepatic and renal functions, as assessed by standard laboratory criteria; left ventricular ejection fraction of ≥ 40 %, as determined by echocardiography or a multigated acquisition scan
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Cancer Center · Jacksonville, Florida
- University of Kansas Cancer Center · Fairway, Kansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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