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A Phase I/IIa, unblinded, multicenter, first-in-human, dose-finding study of MP0533 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) (MP0533-CP101)

This study investigated the safety and efficacy of the investigational product MP0533.

Aim of the study

The study is investigating how safe the investigational product MP0533 is and how well it works. Different doses of MP0533 will be investigated to define the recommended (safest) dose regimen for future studies.

Who can take part?

Patients with acute myeloid leukemia (AML) or myelodysplastic leukemia (MDL). syndrome (MDS) in whom the disease has returned or has not improved under treatment.

Procedure

In the treatment phase, the investigational drug is administered intravenously at the trial site. During the first infusions, the dose is gradually increased until the target dose is reached. During this time, samples and data will be collected to verify the safety and investigate the distribution of the investigational product MP0533.

Compensation

Original study name

A Phase I/IIa, unblinded, multicenter, first-in-human, dose-finding study of MP0533 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)

BASEC number

2022-01615

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