NCT07753148RecruitingPhase 1
Safety and Tolerability of REGN17235 in Adult Participants With Clonal Cytopenia of Undetermined Significance and Low-Risk Myelodysplastic Syndrome With SF3B1 Mutation
An Open-Label, Multi-Center Phase I Study to Investigate the Safety and Tolerability of REGN17235 in Patients With Clonal Cytopenia of Undetermined Significance and Low-Risk Myelodysplastic Syndrome With SF3B1 Mutation
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 3 Aug 2026
- Start date
- 17 Sept 2026
- Primary completion date
- 5 May 2031
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT07753148
- EU CT number
- 2026-525464-18-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 52
- From 17 Sept 2026 to the primary completion date, 5 May 2031
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Recent or uncontrolled infections as described in the protocol
- Diagnosed or treated for malignancy other than MDS as described in the protocol
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ziekenhuis Aan De Stroom Coordinator of this site? Confirm its status | Antwerp | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.