CMBG453B12201

A randomized, double-blind, placebo-controlled phase II multi-center study of intravenous MBG453 added to hypomethylating agents in adult subjects with intermediate, high or very high risk MDS as per IPSS-R criteria

Study treatments

• Arm 1: Decitabine and PDR001 
• Arm 2: Decitabine and MBG453 
• Arm 3: Decitabine, PDR001 and MBG453 

Inclusion criteria

• - Morphologically confirmed diagnosis of MDS based on 2016 WHO classification by investigator assessment with one of the following Prognostic Risk Categories, based on the IPSSR
    - Very high (> 6 points), high (> 4.5-6 points), intermediate (> 3-4.5 points) 
• Not suitable for intensive chemotherapy
• No planned hematopoietic stem-cell transplantation
• ECOG 0-2 

Exclusion

• Prior exposure to TIM-3 directed therapy at any time
• Previous treatment for intermediate, high or very high risk MDS with chemotherapy or other antineoplastic agents including lenalidomide and hypomethylating agent
• Current use or use within 14 days prior to randomization of systemic, steroid therapy (> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy 
• Active autoimmune disease requiring systemic therapy

Participating sites

• University Hospital Leuven Gasthuisberg