Table of contents
Trial overview
The available trial is a study of ANTIBODY MIMETIC PROTEIN BINDING TO T CELLS CD3, TUMOR-ASSOCIATED ANTIGENS CD70, CD33, CD123, AND HUMAN SERUM ALBUMIN in patients with blood cancer.[1]
This study is titled as a study of MP0533 in patients with blood cancer, and it is an interventional trial.[1]
The trial is authorised and has an enrollment of 249 people.[1]
Who can participate
The study is for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), including MDS/AML.[1]
The brief summary says the study is for patients with relapsed or refractory AML and MDS/AML.[1]
Relapsed means the disease came back after treatment, and refractory means the disease did not respond well to prior treatment.
Study phase and goals
This is a Phase 1/2 trial.[1]
In phase 1, the study aims to determine safety and tolerability and to define the recommended phase 2 dose regimen (RP2D-R) and/or the maximum tolerated dose-regimen (MTD-R).[1]
In phase 2a, the study aims to evaluate preliminary anti-leukemic activity, which means early signs that the treatment may help against leukemia.[1]
What the trial measures
The primary outcome in phase 1 is the incidence of CRS and non-CRS DLTs during the first cycle of treatment.[1]
CRS means cytokine release syndrome, a serious immune reaction, and DLT means dose-limiting toxicity, which is a side effect that may limit how much treatment can be given.
The study also measures the type, incidence, and severity of adverse events using the NCI CTCAE v5.0 scale, plus changes in laboratory safety tests and vital signs.[1]
For phase 2a, the main response measure is the overall response rate (ORR) based on best overall response, including complete remission, complete remission with partial hematological recovery (CRh), complete remission with incomplete hematological recovery (CRi), morphologic leukemia-free state (MLFS), and partial remission (PR).[1]
These response categories come from the European LeukemiaNet (ELN) response criteria 2022.[1]
Key trial details
The study intervention list includes MP0533 given by intravenous use, along with Venclyxto 100 mg film-coated tablets taken by mouth and Vidaza 25 mg/ml powder for suspension for injection given by intravenous injection or intravenous infusion.[1]
The trial record does not give more detail here about how the treatment is compared or how the study is organized beyond these listed interventions.[1]
