Swedish company Cantargia has enrolled the first patient in the Phase Ib/IIa trial of nadunolimab for treating individuals with acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS).
This investigator-initiated trial is said to explore the early efficacy and safety post-treatment with the therapy and standard-of-care chemotherapy.
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It aims to enrol a total of 40 patients, with 20 patients each for AML and MDS. The complete recruitment is anticipated in 2027.
The US Department of Defense is funding the trial, with The University of Texas MD Anderson Cancer Center’s Leukemia professor Dr Gautam Borthakur serving as the principal investigator.
The trial is based on a discovery by professor Fioretos and Dr Järås of Lund University, which found that leukaemia stem cells express interleukin1 receptor accessory protein (IL1RAP) on their surface.
Its primary aim is to assess nadunolimab’s safety and recommended dosage when used with standard leukaemia chemotherapies, venetoclax and azacitidine.
Secondary objectives include evaluating the anti-tumour efficacy that is measured by overall response rates as well as the duration of response in subjects with AML and MDS.
The trial also includes comprehensive translational evaluations by examining biomarkers and effects on leukemic cells, as well as hematopoietic subpopulation alterations, with single cell multimodal analysis being conducted at Lund University in Sweden.
Cantargia chief medical officer Dominique Tersago said: “The potential for nadunolimab as anti-cancer therapy is expanded by this important investigator led initiative treating patients with leukaemias.
“This is the first study of nadunolimab in haematological malignancies, and complements the promising results achieved with nadunolimab plus chemotherapy in solid tumour indications.
In November 2024, the company initiated an expanded segment of its ongoing Phase I trial of the antibody CAN10, with the first participant receiving a dose.
