Clinical Research Directory

Key Inclusion Criteria: 1. Presence of SF3B1 mutation in the bone marrow or peripheral blood AND diagnosis of low-risk MDS OR diagnosis of CCUS as defined by WHO 2022, 5th edition as described in the protocol 2. Adequate bone marrow function as described in the protocol; red blood cell transfusion dependence is permitted 3. Adequate hepatic and renal function as described in the protocol Key Exclusion Criteria: 1. Clinically significant anemia due to non-MDS or non-CCUS etiologies (eg, iron deficiency, vitamin B12 or folate deficiency, autoimmune or hereditary hemolysis, or hemorrhage) diagnosed or treated within the last 3 months prior to informed consent 2. Recent or uncontrolled infections as described in the protocol 3. Diagnosed or treated for malignancy other than MDS as described in the protocol 4. Prior treatment with any systemic therapy for MDS or CCUS within 5 half-lives or within 14 days prior to first administration of study drug, whichever is shorter 5. Allogeneic hematopoietic stem cell transplant within 100 days of enrollment or any signs or symptoms of ongoing Graft-Versus Host Disease (GVHD) as described in the protocol Note: Other protocol defined Inclusion/Exclusion Criteria apply