Actively Recruiting
Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia
Led by Disc Medicine, Inc · Updated on 2026-05-13
150
Participants Needed
25
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at consent
- DIPSS score of 3 to 4 (intermediate 2 risk) or 5 (high-risk) primary MF, post PV MF, or post ET MF for Phase 1b; Phase 2 includes DIPSS 2 (intermediate 1 risk)
- At least 28 days washout from androgens, EPO, cladribine, immunomodulators, and certain corticosteroids
- Anemia: Hgb <10 g/dL on 3 assessments over 84 days before screening or specific RBC transfusion dependence criteria
- Stable dosing of MF therapy or required washout for JAK inhibitors and hydroxyurea
- ECOG performance score 2
- No planned hematopoietic stem cell transplant within 8 months after screening
- TSAT <75%
- Liver iron concentration by MRI <7 mg/g dry weight (for TD high participants)
- Serum ferritin 50 bcg/L
- Platelet count 25,000/bcL and <1,000,000/bcL; neutrophils 1,000/bcL; WBC count <50,000/bcL
- eGFR 30 mL/min/1.73 m2
- AST and ALT <3x ULN
- Direct bilirubin <2x ULN or approved exceptions
- Use of effective contraception for participants of childbearing potential
- Negative pregnancy test for females of childbearing potential
- Ability to understand study and provide informed consent
- Ability to comply with study procedures
- For MDS cohort: IPSS-M classification of very low, low, or intermediate risk MDS or related conditions
- Similar washout, anemia, and laboratory criteria as MF cohort
You will not qualify if you...
- Hereditary hemochromatosis
- Hemoglobinopathy or intrinsic RBC defect causing anemia
- Total splenectomy
- Hematopoietic cell transplant within past 2 years (MF) or 10 years (MDS)
- Current anemia from iron, B12, or folate deficiency, infection, or bleeding
- Active immune-mediated hemolytic anemia
- Symptomatic bleeding causing significant hemoglobin drop or transfusion in past 6 months
- Major surgery within 8 weeks prior to screening or incomplete recovery
- Recent malignancy within 3 years except certain skin, cervical, or prostate cancers
- Stroke, deep vein thrombosis, or embolism within 3 months (MF) or 6 months (MDS)
- Known allergy to study drug excipients
- History of anti-drug antibody formation
- Uncontrolled heart disease (NYHA class 3 or 4) or low left ventricular ejection fraction
- Active hepatitis B or C, or HIV with detectable viral load
- Uncontrolled infections despite treatment
- Recent iron chelation therapy or anticoagulant changes
- Peripheral blood myeloblasts 10% (MF) or 5% (MDS)
- Positive direct antiglobulin test with reactive RBC eluate
- Pregnant or lactating
- Conditions or medications interfering with study data
- Participation in other investigational studies within 30 days of screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
City of Hope - Duarte
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope - Lennar
Irvine, California, United States, 92618
Actively Recruiting
3
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Sylvester Cancer Center - U Miami
Miami, Florida, United States, 33136
Actively Recruiting
6
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
7
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
10
Washington University St.Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
12
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
13
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
14
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Terminated
15
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
16
The Ohio State University
Columbus, Ohio, United States, 43201
Actively Recruiting
17
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
18
Sargon Research - Pennsylvania Cancer Specialists and Research Center
Gettysburg, Pennsylvania, United States, 17325
Withdrawn
19
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
20
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
21
University of Washington
Seattle, Washington, United States, 98109
Actively Recruiting
22
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
23
Linear Clinical Research
Nedlands, Australia, 6009
Actively Recruiting
24
St. Vincent's Hospital
Sydney, Australia, 2010
Actively Recruiting
25
Perth Blood Institute
West Perth, Australia, 6005
Actively Recruiting
Research Team
D
Disc Medicine Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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