REGN17235 for CCUS and LR-MDS with SF3B1 mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study investigates REGN17235 in adults who have CCUS or low-risk myelodysplastic syndrome with an SF3B1 mutation. It aims to characterize safety and tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy to guide dose selection. Primary goals include identifying adverse effects and determining the best dose; secondary goals assess drug levels over time and any antibody responses that might reduce efficacy. The trial will enroll participants with adequately functioning bone marrow and organ systems, and excludes those with significant anemia from non-MDS/CCUS causes or recent uncontrolled infections. The study is conducted at selected sites in Ghent, Belgium.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. 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
2. Adequate bone marrow function as described in the protocol; red blood cell transfusion dependence is permitted
3. Adequate hepatic and renal function as described in the protocol

Key Exclusion Criteria:

1. 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
2. Recent or uncontrolled infections as described in the protocol
3. Diagnosed or treated for malignancy other than MDS as described in the protocol
4. 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
5. 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

Where it's running

• Uz Ghent
  Ghent, Belgium Recruiting
• Algemeen Ziekenhuis (AZ) Delta
  Roeselare, Belgium Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.