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
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
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
Single group
REGN17235
DrugAdministered per the protocol
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Severity of TEAEs
Occurrence of Serious Adverse Events (SAEs)
Severity of SAEs
Hematologic improvement per International Working Group (IWG) 2018
Concentration of REGN17235 in serum
Occurrence of Anti-Drug Antibodies (ADA) to REGN17235 in serum
Magnitude of ADA to REGN17235 in serum
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This trial is not recruiting at the moment. You can still explore other options:
