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

NCT07753148 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-08-07

No results posted yet for this study

Summary

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

Conditions

  • Clonal Cytopenia of Undetermined Significance (CCUS)
  • Low-Risk Myelodysplastic Syndrome (LR-MDS)

Interventions

DRUG

REGN17235

Administered per the protocol

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-17
Primary Completion
2031-05-05
Completion
2031-05-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07753148 on ClinicalTrials.gov