OncoMatch/Clinical Trials/NCT04419649
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)
Is NCT04419649 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Elritercept for myelodysplastic syndromes.
Treatment: Elritercept — The main aim of this study is to learn how safe elritercept is and how well adults with anemia associated with lower-risk MDS tolerate treatment with different doses of elritercept. Other aims are to learn how safe elritercept is by looking at how many participants have MDS that worsens during the study and learn about the effects of elritercept on anemia linked to MDS. The study will also look to learn how elritercept affects the production of healthy RBCs.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: hypomethylating agent (azacitidine, decitabine)
Prior treatment with azacitidine, decitabine
Cannot have received: immunomodulatory agent (lenalidomide)
Prior treatment with lenalidomide
Cannot have received: erythroid maturation agent (luspatercept, sotatercept)
Prior treatment with luspatercept or sotatercept
Cannot have received: erythropoiesis-stimulating agent
Treatment with ESA within 56 days prior to C1D1
Cannot have received: G-CSF or GM-CSF
Exception: Previous treatment for MDS, discontinued ≥ 8 weeks prior to C1D1 is allowed
Prior or concurrent chronic treatment with G-CSF or GM-CSF
Cannot have received: iron chelation therapy
Exception: Participants on stable doses for ≥ 8 weeks are allowed
Iron chelation therapy if initiated within 8 weeks prior to C1D1
Cannot have received: vitamin B12 and/or folate therapy
Exception: Participants on stable replacement doses for ≥ 8 weeks and without concurrent vitamin B12 or folate deficiency are allowed
Vitamin B12 and/or folate therapy initiated within 8 weeks prior to C1D1
Cannot have received: investigational drug or device or approved therapy for investigational use
Treatment with another investigational drug or device or approved therapy for investigational use within 8 weeks prior to C1D1, or, if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer
Lab requirements
Blood counts
Platelet count 25-450 × 10^9/L (Part 2); 30-450 × 10^9/L (Part 1); Peripheral WBC count < 13,000/μL; Transferrin saturation ≥ 15%; Ferritin ≥ 50 ng/mL; Folate ≥ 4.5 nmol/L (≥ 2.0 ng/mL); Vitamin B12 ≥ 148 pmol/L (≥ 200 pg/mL)
Kidney function
Estimated GFR ≥ 30 mL/min/1.73 m^2 as determined by the CKD-EPI equation
Liver function
No diagnosis of cirrhosis, non-alcoholic steatohepatitis, alcoholic liver disease, hepatitis, or other liver disease (acute or chronic) meeting Child-Pugh C criteria for hepatic impairment. Participants with elevated liver enzymes are allowed if the liver enzyme elevation is suspected to be due to iron-overload or iron chelation, and other hepatic causes have been ruled out, in the opinion of the Investigator.
Cardiac function
No uncontrolled heart disease or NYHA Class III or IV heart failure; QTcF ≤ 500 msec; No uncontrolled clinically significant arrhythmia (rate-controlled atrial fibrillation allowed); No acute myocardial infarction or unstable angina pectoris ≤ 6 months prior to C1D1; No uncontrolled hypertension (systolic BP < 160 mmHg and diastolic BP < 100 mmHg despite adequate treatment)
See laboratory and cardiac exclusion criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope National Medical Center · Duarte, California
- University of Miami School of Medicine Sylvester Comprehensive Cancer Center (SCCC) · Miami, Florida
- H. Lee Moffitt Cancer Center and Research Center · Tampa, Florida
- Karmanos Cancer Institute at Mclaren Greater Lansing · Lansing, Michigan
- University of Pittsburgh Medical Health Center · Pittsburgh, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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