Safety and Tolerability of REGN17235 in Adult Participants With Clonal Cytopenia of Undetermined Significance and Low-Risk Myelodysplastic Syndrome With SF3B1 Mutation

Key Inclusion Criteria:

• 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
• Adequate bone marrow function as described in the protocol; red blood cell transfusion dependence is permitted
• Adequate hepatic and renal function as described in the protocol

Key Exclusion Criteria:

• 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
• Recent or uncontrolled infections as described in the protocol
• Diagnosed or treated for malignancy other than MDS as described in the protocol
• 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
• 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