OncoMatch/Clinical Trials/NCT06499285
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants With Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)
Is NCT06499285 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies Elritercept for myelodysplastic syndromes.
Treatment: Elritercept — The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Myelodysplastic Syndrome
Biomarker criteria
Excluded: DEL(5Q) deletion
Disease stage
Required: Stage VERY LOW, LOW, INTERMEDIATE (other)
IPSS-R classification of very low, low, or intermediate risk disease
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: erythropoiesis-stimulating agent (recombinant human erythropoietin, darbepoetin alpha)
Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment
Cannot have received: elritercept
Prior use of elritercept
Cannot have received: luspatercept
Prior use of luspatercept
Cannot have received: sotatercept
Prior use of sotatercept
Cannot have received: hypomethylating agent
Prior use of hypomethylating agents (HMAs)
Cannot have received: isocitrate dehydrogenase inhibitor
Prior use of isocitrate dehydrogenase inhibitor
Cannot have received: immunomodulatory agent (lenalidomide)
Prior use of lenalidomide
Cannot have received: telomerase inhibitor (imetelstat)
Prior use of imetelstat
Cannot have received: immunosuppressive therapy for MDS
Prior use of immunosuppressive therapy given for treatment of MDS
Lab requirements
Blood counts
Platelet count >25 × 10^9/L and <800 × 10^9/L; absolute neutrophil count >500/µL; ferritin >50 μg/L; folate >2.0 ng/mL; vitamin B12 >200 pg/mL
Kidney function
Estimated glomerular filtration rate ≥30 mL/min/1.73m^2 (CKD-EPI equation)
Liver function
Serum aspartate aminotransferase or alanine aminotransferase <3 × ULN; total bilirubin <2 × ULN unless attributable to Gilbert's syndrome; Child-Pugh class C hepatic impairment excluded
Cardiac function
No NYHA class III/IV heart disease; QTcF ≤500 ms; ejection fraction ≥35%; no uncontrolled hypertension (SBP <160 mmHg, DBP <100 mmHg); no uncontrolled arrhythmia, MI, or unstable angina within 6 months
Clinically significant cardiovascular disease defined as: 1. New York Heart Association heart disease class III or IV; 2. Fridericia corrected QT (QTcF) interval >500 milliseconds during Screening; 3. Presence of uncontrolled hypertension defined as mean systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg during Screening; or 4. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before Screening. Known ejection fraction <35%, confirmed by a local echocardiogram performed during Screening, or a previously performed echocardiogram if collected within 6 months before Screening. Child-Pugh class C hepatic impairment. Estimated glomerular filtration rate <30 mL/min/1.73m^2. Platelet count ≥800 × 10^9/L or ≤25 × 10^9/L. Absolute neutrophil count ≤ 500/µL. Serum aspartate aminotransferase or alanine aminotransferase ≥3 × ULN. Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome. Ferritin ≤ 50 μg/L. Folate ≤2.0 ng/mL. Vitamin B12 ≤200 pg/mL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- Los Angeles Cancer Network · Glendale, California
- UC San Diego Moores Cancer Center · La Jolla, California
- Smilow Cancer Hospital at Yale-New Haven · New Haven, Connecticut
- University of Miami Hospital and Clinics · Miami, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06499285 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior elritercept, luspatercept, sotatercept disqualifies patients from enrollment.
Are patients with DEL(5Q) alterations eligible?
No. DEL(5Q) deletion is an exclusion criterion.
What disease stage is eligible?
Stage VERY LOW or LOW or INTERMEDIATE is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages