Single-arm open label phase II study of MBG453 (sabatolimab) added to FDA approved Hypomethylating agents of investigator s choice (IV/SC/Oral) for patients with intermediate high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R criteria (US multi-center) (STIMULUS MDS-US)

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Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Other Inclusion Criteria:

1) Morphologically confirmed diagnosis of a myelodysplastic syndrome (MDS) primary or secondary. 2) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. 3) AST and ALT = 3 × upper limit of normal (ULN). 4) Total bilirubin = 2 × ULN (except in the setting of isolated Gilbert syndrome).

1) Prior exposure to T-cell immunoglobulin domain and mucin domain-3 (TIM-3) directed therapy at any time and prior therapy with immune checkpoint inhibitors (e.g. anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2). 2) Previous treatment for intermediate, high or very high risk myelodysplastic syndromes (based on IPSS-R) with chemotherapy or other antineoplastic agents including lenalidomide and hypomethylating agent (HMAs) with the exception of once cycle of Hypomethylating agent (1 cycle allowed). 3) History of severe hypersensitivity reactions to any ingredient of study drug(s) (azacitidine, decitabine, INQOVI (oral decitabine) or MBG453 (sabatolimab)) or monoclonal antibodies (mAbs) and/or their excipients.