Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)
The primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML).
Men and women ≥ 18 years of age Documented diagnosis of myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML), white blood cells (WBC) ≤ 13,000 /mm^3, World Health Organization (WHO) that meets International Prognostic Scoring System (IPSS) criteria for low or intermediate-1 risk disease Anemia, Hemoglobin (Hgb) ≤ 9.0 g/dL or ≥ 2 units of Red Blood Cells (RBCs) within 84 days No response or loss of response to Erythropoiesis-Stimulating Agents (ESAs) or erythropoetin (EPO) > 500 mU/ml Eastern Cooperative Group (ECOG) score ≤2. Creatinine < 1.5 * Upper Limit of the Normal (ULN) Total bilirubin ≤3.0 mg/dL Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT) & Alanine Aminotransferase (ALT)/Serum Glutamic Pyruvic (SGPT) ≤3.0 * Upper Limit of Norma (ULN) Free of metastatic malignancy (other than MDS) for ≥2 years Highly effective methods of birth control for females and males
Exclusion Criteria:
Chromosome 5q deletion Pregnant or breast feeding women and males who do not agree to use condom during the sexual contact with females of childbearing potential Major surgery within 30 days Incomplete recovery or incomplete healing of wounds from previous surgery Heart failure ≥3 (New York Heart Association (NYHA)) Thromboembolic or myocardial infarction event within 6 months Concurrent anti-cancer cytotoxic chemotherapy History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant protein Known positive for Human Immunovirus (HIV) or infectious Hepatitis type C or active infectious Hepatitis type B Clinically significant anemia unrelated to MDS Thrombocytopenia (<30,000/uL) Uncontrolled hypertension Treatment with another investigational drug or device within 28 days prior to Day 1 Prior exposure to sotatercept (ACE-011) Any serious medical condition, lab abnormality or psychiatric illness