RecruitingPhase 1Phase 2NCT05320198

Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia

RALLY-MF: A Phase 1b/2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of DISC-0974 in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia

Sponsor

Disc Medicine, Inc

Enrollment

150 participants

Start Date

Jun 6, 2022

Study Type

INTERVENTIONAL

Conditions

Myelodysplastic Syndromes Myelofibrosis Anemia Primary Myelofibrosis Post-essential Thrombocythemia Myelofibrosis Myelofibrosis; Anemia Myelofibrosis Due to and Following Polycythemia Vera

Summary

This phase 1b/2a open-label study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of DISC-0974 as well as categorize the effects on anemia response in subjects with myelofibrosis or myelodysplastic syndrome and anemia.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an injectable drug called DISC-0974 in people with myelofibrosis (MF) or myelodysplastic syndrome (MDS) who have anemia (low red blood cell levels). The drug targets a hormone pathway involved in regulating red blood cell production, which may reduce the need for blood transfusions. You may be eligible if... - You are 18 or older - You have been diagnosed with myelofibrosis or myelodysplastic syndrome (MDS) - You have anemia — either low hemoglobin levels (below 10 g/dL) or you depend on regular blood transfusions - You are on a stable dose of MF or MDS medications - Your blood counts, kidney, and liver values meet specific thresholds - You are willing to use contraception if applicable You may NOT be eligible if... - You have hereditary hemochromatosis or a blood condition causing anemia unrelated to MF/MDS - You have had a stem cell transplant in the past 2 years (or 10 years for MDS) - You have had a recent major bleeding episode, surgery, or blood clot - You have poorly controlled heart disease - You have active hepatitis B, C, or HIV - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDISC-0974

DISC-0974 is administered subcutaneously.

Locations(25)

City of Hope - Duarte

Duarte, California, United States

City of Hope - Lennar

Irvine, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Sylvester Cancer Center - U Miami

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory Winship Cancer Institute

Atlanta, Georgia, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Washington University St.Louis

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Gabrail Cancer Center Research

Canton, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Sargon Research - Pennsylvania Cancer Specialists and Research Center

Gettysburg, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

MD Anderson

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Linear Clinical Research

Nedlands, Australia

St. Vincent's Hospital

Sydney, Australia

Perth Blood Institute

West Perth, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05320198

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