This study will test a study drug called REGN17235 (the "study drug") to see if it can help treat Clonal Cytopenia of Undetermined Significance (CCUS) and Low-Risk Myelodysplastic Syndrome (LR-MDS) with a specific genetic mutation (SF3B1 Mutation). The study is looking at: * What side effects the study drug might cause * How well the study drug works * How much of the study drug is in the blood at different times * If the body makes antibodies (proteins that attach to substances your body does not recognize) against the study drug; this may cause the study drug to not work as well. * What is the best dose of the study drug to treat CCUS and LR-MDS
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Administered per the protocol
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 5 years
Severity of TEAEs
Time frame: Up to 5 years
Occurrence of Serious Adverse Events (SAEs)
Time frame: Up to 5 years
Severity of SAEs
Time frame: Up to 5 years
Hematologic improvement per International Working Group (IWG) 2018
Time frame: Up to 5 years
Concentration of REGN17235 in serum
Time frame: Up to 5 years
Occurrence of Anti-Drug Antibodies (ADA) to REGN17235 in serum
Time frame: Up to 5 years
Magnitude of ADA to REGN17235 in serum
Time frame: Up to 5 years
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