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RecruitingNCT05320198Updated Oct 22, 2026

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

A Phase 1/2 interventional study of DISC-0974 in Myelofibrosis; Anemia, Anemia and Myelofibrosis, sponsored by Disc Medicine, Inc. Recruiting at 35 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Disc Medicine, Inc · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 5 months later.
Updated Oct 22, 20263 sites addedGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

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

Keywords

  • Myeloproliferative Neoplasm
  • Myeloproliferative Disorders
03

In context

Primary Myelofibrosis

625 studies on the registry are indexed under Primary Myelofibrosis; 124 are open to participants now.

This study's planned enrollment of 150 is above the median of 43 across 489 interventional studies indexed under Primary Myelofibrosis.

Browse Primary Myelofibrosis studies →

Lead sponsor

Disc Medicine, Inc is the lead sponsor of 11 studies on the registry; 5 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria for Participants with MF and Anemia:

Participants are eligible for the study if all of the following criteria apply:

  1. Age 18 years or older at the time of signing the form (ICF).

  2. For Phase 1b: Dynamic International Prognostic Scoring System (DIPSS) score of 3 to 4 (intermediate 2 risk) or ≥5 (high-risk) primary MF, post PV MF, and/or post ET MF, as confirmed in the most recent local bone marrow report, according to World Health Organization (WHO) 2016 criteria.

    For Phase 2: In addition to the criteria above, DIPSS score of ≥2 (intermediate 1 risk) may also be included.

  3. of at least 28 days prior to Screening of the following treatments:

    1. Androgens
    2. EPO
    3. Cladribine
    4. Immunomodulators (lenalidomide, thalidomide)
    5. Luspatercept/sotatercept
    6. Systemic are permitted for non-hematological conditions if stable or decreasing dose for ≥28 days prior to Screening and receiving an equivalent to ≤10 mg prednisone for the 28 days immediately prior to Screening.

    Screening can begin before the 28 day washout is completed, but the washout period must be completed prior to collection of Screening blood samples.

  4. Anemia:

    For Phase 1b: \<10 g/dL on ≥3 assessments over 84 days prior to Screening, without RBC transfusion, or Hgb \<10 g/dL and receiving RBC transfusions periodically but not meeting criteria for TD participant as defined for the TD cohort. The baseline Hgb value for these participants is the lowest Hgb level during the 84 days prior to Screening, or RBC transfusion dependence, defined as an RBC transfusion frequency of ≥6 units PRBC over the 84 days immediately prior to Screening. There must not be any consecutive 42-day period without an RBC transfusion in the 84-day period, and the last transfusion must be within 28 days prior to Screening.

    For Phase 2:

    TD high transfusion burden cohort: RBC transfusion dependence, defined as an RBC transfusion requirement of 3 to 12 PRBC units over the 84 days immediately prior to Screening TD low transfusion burden cohort: RBC transfusion dependence, defined as an RBC transfusion requirement of 1 to 2 PRBC units over the 84 days immediately prior to Screening nTD Cohort: Non-transfusion dependence, baseline Hgb \<10 g/dL as defined on ≥3 assessments over 84 days prior to Screening, without RBC transfusion

  5. Stable dosing of MF-directed therapy:

    1. Hydroxyurea, or, if taking any other treatment for MF, stable for at least 28 days prior to Screening.
    2. Interferon alpha stable dosing for at least 12 weeks prior to Screening.
    3. JAK inhibitors require 12 weeks of stable dosing prior to Screening. For the TD high, TD low, and nTD cohorts, JAK inhibitors allowed include momelotinib, pacritinib, fedratinib, and ruxolitinib.
    4. If the participant discontinues JAK inhibitor (including momelotinib/pacritinib/ruxolitinib/fedratinib) and/or hydroxyurea prior to Screening, a 60-day washout period is required.
  6. (ECOG) performance score ≤2.
  7. Infusion of hematopoietic stem cell transplant not anticipated within 8 months after Screening.
  8. TSAT \<75% (local lab acceptable) at or within 2 weeks of Screening.
  9. Liver iron concentration by MRI \<7 mg/g dry weight within 3 months of eligibility confirmation by central review. Required for TD high participants only.
  10. Serum ferritin ≥50 µg/L at Screening.
  11. count ≥25,000/µL and \<1,000,000/µL; neutrophils ≥1,000/µL; and total white blood cell (WBC) count \<50,000/µL at Screening.
  12. Estimated (eGFR) ≥30 mL/min/1.73 m2 by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula.
  13. (AST) and ALT \<3.0x (ULN) at Screening.
  14. Direct \<2x ULN at Screening. Higher levels are acceptable if these can be attributed by the Investigator to ineffective erythropoiesis or Gilbert's syndrome, with approval from Sponsor.

  15. If male with female sexual partner(s) of , agrees to use 1 of the following highly effective methods of during the study and for at least 8 weeks after the last study drug dose:

    1. Stable hormonal contraceptive (≥3 months; female partner)
    2. Intrauterine device in place for at least 3 months (female partner)
    3. Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner)
    4. Confirmed successful vasectomy

  16. If female, then EITHER (defined as 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels >40 mIU/ml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) on Day 1 (or earlier) and for at least 8 weeks after the last dose of study drug:

    1. Stable hormonal contraceptive (≥3 months)
    2. Intrauterine device in place for at least 3 months
    3. Tubal ligation or single male partner with vasectomy
  17. Negative urine pregnancy test (females of childbearing potential) at Screening (Days 28 to 2).
  18. Able to understand the study aims, procedures, and requirements, and provide written informed consent.
  19. Able to comply with all study procedures.

Inclusion Criteria for Exploratory Cohort of Participants with MDS and Anemia:

Participants are eligible for the MDS exploratory cohort if all of the following criteria apply:

  1. Age 18 years or older at the time of signing the ICF.
  2. Molecular International Prognostic Scoring System (IPSS-M) classification of very low, low, or intermediate (ie, lower risk) MDS-ringed sideroblasts (RS) negative, MDS/MPN with ringed sideroblasts and thrombocytosis (RS-T), Chronic Myelomonocytic Leukemia (CMML), Atypical Chronic Myeloid Leukemia (aCML), or Myelodysplastic/Myeloproliferative Neoplasms, Unclassifiable (MDS/MPN-U) as confirmed in the most recent local bone marrow biopsy report according to WHO criteria.

  3. Washout of at least 28 days is required for prior anemia/neutropenia-directed therapies, including:

    1. Androgens
    2. EPO-stimulating agents
    3. Luspatercept
    4. Sotatercept (ACE-011)
    5. Imetelstat
    6. Granulocyte colony-stimulating factor (G CSF) OR granulocyte-macrophage CSF (GM CSF).
    7. Systemic corticosteroids (except for participants on a stable or decreasing dose for ≥28 days prior to randomization for non-hematological conditions and receiving an equivalent to ≤10 mg prednisone for the 28 days immediately prior to Screening) Screening can begin before the 28-day washout is completed, but the washout period must be completed prior to collection of Screening blood samples.

  4. Anemia:

    1. Baseline Hgb of \<10 g/dL on ≥3 assessments over 84 days prior to Screening, without RBC transfusion, or Hgb \<10 g/dL and receiving RBC transfusions periodically during the 84 days prior to Screening
    2. Medical history of ≤24 units of PRBC for MDS and anemia
  5. ECOG performance score ≤2
  6. Infusion of hematopoietic stem cell transplant not anticipated within 8 months after Screening
  7. TSAT \<75% (local lab acceptable) at or within 2 weeks of Screening
  8. Liver iron concentration by MRI \<7 mg/g dry weight within 3 months of eligibility confirmation by central review
  9. Serum ferritin ≥50 μg/L at Screening
  10. Platelet count ≥25,000/μL and \<1,000,000/μL, and total WBC count \<50,000/μL at Screening or otherwise approved by Sponsor.
  11. eGFR ≥30 mL/min/1.73 m2 by the CKD-EPI formula
  12. AST and ALT \<3x ULN at Screening
  13. Direct bilirubin \<2x ULN at Screening. Higher levels are acceptable if these can be attributed by the Investigator to ineffective erythropoiesis.

  14. If male with female sexual partner(s) of childbearing potential, agrees to use 1 of the following highly effective methods of contraception during the study and for at least 8 weeks after the last study drug dose:

    1. Stable hormonal contraceptive (≥3 months; female partner)
    2. Intrauterine device in place for at least 3 months (female partner)
    3. Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner)
    4. Confirmed successful vasectomy

  15. If female, then EITHER postmenopausal (defined as 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/ml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) on Day 1 (or earlier) and for at least 8 weeks after the last dose of study drug:

    1. Stable hormonal contraceptive (≥3 months)
    2. Intrauterine device in place for at least 3 months
    3. Tubal ligation or single male partner with vasectomy
  16. Negative urine pregnancy test (females of childbearing potential) at Screening (Days 28 to 2).
  17. Able to understand the study aims, procedures, and requirements, and provide written informed consent.
  18. Able to comply with all study procedures.

Exclusion Criteria for Participants with MF and Anemia:

Participants are excluded from the study if any of the following criteria apply:

Medical History, Participants with MF and Anemia

  1. Hereditary hemochromatosis
  2. Hemoglobinopathy or intrinsic RBC defect associated with anemia
  3. Total splenectomy
  4. Hematopoietic cell transplant within the past 2 years, or graft vs host disease requiring
  5. Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or bleeding
  6. Active immune-mediated hemolytic anemia
  7. Symptomatic bleeding, unrelated to surgery, in a critical area or organ and/or bleeding causing a decrease in Hgb of ≥2 g/dL or leading to transfusion of ≥2 units of RBCs in the 6 months prior to Screening
  8. Major surgery within 8 weeks prior to Screening or incomplete recovery from any previous surgery

  9. within the past 3 years, other than primary MF, post ET, or post PV MF. The following history or concurrent conditions are allowed:

    1. basal or squamous cell carcinoma of the skin
    2. carcinoma in situ of the cervix or the breast
    3. histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, [TNM] clinical staging system) A history of completed treatment (medical or surgical) of stage 1-2 cancers may be permitted with prior Sponsor agreement
  10. Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 3 months prior to Screening
  11. Known allergic reaction to any study drug
  12. A history of anti-drug antibody formation
  13. Inadequately controlled heart disease ( Classification 3 or 4) and/or known to have \<35%
  14. or C, or (HIV) with detectable viral load

  15. Uncontrolled fungal, bacterial, or viral infection (ongoing signs/symptoms related to the infection, without improvement despite appropriate treatment)

    Treatment History, Participants with MF and Anemia

  16. Iron chelation therapy in the 28 days prior to Screening

  17. Change in anticoagulant therapy regimen within 8 weeks prior to Screening

    Laboratory Exclusions, Participants with MF and Anemia

  18. Peripheral blood myeloblasts ≥10% of WBC differential at most recent evaluation prior to Screening

  19. Positive direct antiglobulin test in conjunction with a reactive RBC eluate at Screening

    Miscellaneous, Participants with MF and Anemia

  20. Pregnant or lactating
  21. Condition or concomitant medication that would confound the ability to interpret study data
  22. Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the Investigator or Sponsor, would put the participant at unacceptable risk or otherwise preclude the participant from participating in the study
  23. Participation in any other clinical protocol or study that involves administration of experimental therapy and/or therapeutic devices within 30 days prior to Screening

Exclusion Criteria for Exploratory Cohort of Participants with MDS and Anemia:

Participants are excluded from the MDS exploratory cohort if any of the following criteria apply:

Medical History, Participants with MDS and Anemia

  1. Secondary MDS, ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation from other diseases
  2. Peripheral blasts ≥5%
  3. Current treatment with hypomethylating agent or other acute myeloid leukemia (AML)-like combination chemotherapy or planned use within 6 months after Screening

  4. Prior treatment with >3 anemia-directed therapies (unless otherwise approved by Sponsor) including:

    1. Luspatercept
    2. Sotatercept (ACE-011)
    3. EPO-stimulating agent
    4. Imetelstat
  5. Hereditary hemochromatosis
  6. Hemoglobinopathy or intrinsic RBC defect associated with anemia
  7. Total splenectomy
  8. Hematopoietic cell transplant within the past 10 years
  9. Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or bleeding
  10. Active immune-mediated hemolytic anemia
  11. Symptomatic bleeding, unrelated to surgery, in a critical area or organ and/or bleeding causing a decrease in Hgb of ≥2 g/dL or leading to transfusion of ≥2 units of RBCs in the 6 months prior to Screening
  12. Major surgery within 8 weeks prior to Screening or incomplete recovery from any previous surgery

  13. Malignancy within the past 3 years, other than MDS or MDS/MPN without excess blasts. The following history or concurrent conditions are allowed:

    1. Basal or squamous cell carcinoma of the skin
    2. Carcinoma in situ of the cervix or the breast
    3. Histologic finding of prostate cancer (T1a or T1b using the TNM clinical staging system) A history of completed treatment (medical or surgical) of stage 1-2 cancers may be permitted with prior Sponsor agreement
  14. Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 6 months prior to Screening
  15. Known allergic reaction to any study drug excipient
  16. A history of antidrug antibody formation
  17. Inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and/or known to have left ventricular ejection fraction \<35%
  18. Active hepatitis B or C, or HIV with detectable viral load

  19. Uncontrolled fungal, bacterial, or viral infection (ongoing signs/symptoms related to the infection, without improvement despite appropriate treatment)

    Treatment History, Participants with MDS and Anemia

  20. Iron chelation therapy in the 28 days prior to Screening

  21. Change in anticoagulant therapy regimen within 8 weeks prior to Screening

    Laboratory Exclusions, Participants with MDS and Anemia

  22. Positive direct antiglobulin test in conjunction with a reactive RBC eluate at Screening

    Miscellaneous, Participants with MDS and Anemia

  23. Pregnant or lactating
  24. Condition or concomitant medication that would confound the ability to interpret study data
  25. Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the Investigator or Sponsor, would put the participant at unacceptable risk or otherwise preclude the participant from participating in the study
  26. Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and/or therapeutic devices within 30 days prior to Screening
Terms in these criteria, in plain language(23)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Phase 1b: Dose Escalation

    In the Phase 1b (dose-escalation) portion of the study, DISC-0974 will be administered subcutaneously every 4 weeks.

    Drug: DISC-0974

  • Experimental
    Phase 2: Expansion

    In the Phase 2 (expansion) portion of the study, DISC-0974 will be administered subcutaneously every 4 weeks.

    Drug: DISC-0974

Interventions

  • DrugDISC-0974

    DISC-0974 is administered subcutaneously.

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability of DISC-0974 (Phase 1b only)

    Assessed by treatment-emergent adverse events

    Time frame: From Day 1 to the end of treatment on Day 169

  2. Safety and Tolerability of DISC-0974 (Phase 1b only)

    Assessed by vital signs through blood pressure (mmHg), heart rate (bpm), respiration rate (breaths/min), and temperature (°C)

    Time frame: From Day 1 to the end of treatment on Day 169

  3. Safety and Tolerability of DISC-0974 (Phase 1b only)

    Assessed by physical examinations

    Time frame: From Day 1 to the end of treatment on Day 169

  4. Safety and Tolerability of DISC-0974 (Phase 1b only)

    Assessed by electrocardiogram (ECG) parameters: heart rate, PR interval, QRS duration, QRS axis, QT interval, and QTcF interval)

    Time frame: From Day 1 to the end of treatment on Day 169

  5. Safety and Tolerability of DISC-0974 assessed through blood testing (Phase 1b only)

    The blood testing will include a hematology panel, blood chemistry panel, serology/virology panel, biomarker assessments, PK assessments, and Anti-Drug Antibodies

    Time frame: From Day 1 to the end of treatment on Day 169

  6. Safety and Tolerability of DISC-0974 assessed through urine testing (Phase 1b only)

    The urine testing will include a urinalysis

    Time frame: From Day 1 to the end of treatment on Day 169

  7. Transfusion-dependent (TD) high cohort: transfusion independence (Phase 2 only)

    Defined as the absence of packed red blood cell (PRBC) transfusions over any rolling 12-week interval during the treatment period with a minimum hemoglobin (Hgb) of 7 g/dL. Participants meeting this criterion will be considered to have a major response to treatment.

    Time frame: From Day 1 to the end of treatment on Day 169

  8. TD low cohort: transfusion independence (Phase 2 only)

    Defined as the absence of PRBC transfusions over any rolling 16-week interval during the treatment period with a minimum Hgb of 7 g/dL. Participants meeting this criterion will be considered to have a major response to treatment.

    Time frame: From Day 1 to the end of treatment on Day 169

  9. Non-transfusion-dependent (nTD) cohort: anemia response (Phase 2 only)

    Defined as the composite of the absence of transfusions over any rolling 12-week period and a concomitant mean Hgb increase of ≥1.5 g/dL over baseline. Participants meeting this criterion will be considered to have a major response to treatment.

    Time frame: From Day 1 to the end of treatment on Day 169

Secondary outcomes

  1. Anemia response defined per IWG-MRT 2006 criteria (Phase 1b only)

    Response in nTD participants is defined as ≥2.0 g/dL increase from baseline in Hgb levels. Response in TD participants requires absence of PRBC transfusions during any rolling 12-week period during the treatment period, capped by an Hgb level of ≥8.5 g/dL.

    Time frame: From Day 1 to the end of treatment on Day 169

  2. TD high and TD low participants will be evaluated for absence of PRBC transfusions for any rolling 12-week interval during the treatment period (Phase 1b only)

    Time frame: From Day 1 to the end of treatment on Day 169

  3. TD high participants will be evaluated for absence of PRBC transfusions with minimum Hgb of 7 g/dL during any rolling 12-week interval during the treatment period (Phase 1b only)

    Time frame: From Day 1 to the end of treatment on Day 169

  4. TD low participants will be evaluated for absence of PRBC transfusions with minimum Hgb of 7 g/dL during any rolling 16-week interval during the treatment period (Phase 1b only)

    Time frame: From Day 1 to the end of treatment on Day 169

  5. nTD participants will be evaluated for ≥1.5 g/dL increase from baseline Hgb levels during the treatment period (Phase 1b only)

    Time frame: From Day 1 to the end of treatment on Day 169

  6. nTD participants will be evaluated for the composite of the absence of transfusions over any rolling 12-week period and a concomitant mean Hgb increase of ≥1.5 g/dL over baseline (Phase 1b only)

    Time frame: From Day 1 to the end of treatment on Day 169

  7. Incidence of TEAEs following repeated DISC-0974 SC doses in participants with myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) without excess blasts (collectively referred to as MDS) and anemia (Phase 1b only)

    Proportion of participants with treatment-emergent adverse events

    Time frame: From Day 1 to the end of treatment on Day 169

  8. Incidence of clinically abnormal vital signs following repeated DISC-0974 SC doses in participants with myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) without excess blasts and anemia (Phase 1b only)

    Time frame: From Day 1 to the end of treatment on Day 169

  9. Incidence of clinically abnormal physical exam following repeated DISC-0974 SC doses in participants with myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) without excess blasts and anemia (Phase 1b only)

    Time frame: From Day 1 to the end of treatment on Day 169

  10. Incidence of clinically abnormal electrocardiograms (ECGs) following repeated DISC-0974 SC doses in participants with myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) without excess blasts and anemia (Phase 1b only)

    Time frame: From Day 1 to the end of treatment on Day 169

  11. Incidence of abnormal laboratory test results following repeated DISC-0974 SC doses in participants with myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) without excess blasts and anemia (Phase 1b only)

    Time frame: From Day 1 to the end of treatment on Day 169

  12. Pharmacokinetic data of DISC-0974 following repeated SC doses in participants with myelodysplastic syndrome (MDS) or MDS/myeloproliferative neoplasm (MPN) without excess blasts and anemia (Phase 1b only)

    Pharmacokinetic parameters include DISC-0974 pre-dose concentrations at different visits

    Time frame: From Day 1 to the end of treatment on Day 169

  13. Proportion of participants achieving a mean Hgb increase ≥1 g/dL or ≥2 g/dL from baseline over any rolling 12-week period in absence of PRBC transfusions in each cohort (Phase 1b and 2)

    Participants who are nTD and achieve a mean Hgb increase ≥1 g/dL from baseline over any rolling 12-week period in the absence of transfusion will be considered to have a minor response to treatment.

    Time frame: From Day 1 to the end of treatment on Day 169

  14. PD markers of mechanism engagement, including exploratory cohorts assessed through serum iron levels (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  15. PD markers of mechanism engagement, including exploratory cohorts assessed through TSAT levels (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  16. PD markers of mechanism engagement, including exploratory cohorts assessed through Ferritin levels (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  17. PD markers of mechanism engagement, including exploratory cohorts assessed through Transferrin levels (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  18. PD markers of mechanism engagement, including exploratory cohorts assessed through Serum-hepcidin-25 levels (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  19. Hematologic Parameters assessed through Reticulocyte count (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  20. Hematologic Parameters assessed through Hemoglobin levels (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  21. Hematologic Parameters assessed through Reticulocyte Hemoglobin (CHr) (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  22. Hematologic Parameters assessed through Red Blood Cell Count (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  23. Rate of RBC transfusions per participant month during the treatment period for each cohort (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  24. The number of units of RBC transfusions per participant month during the treatment period for each cohort (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  25. Transfusion-dependent cohorts will be evaluated for proportion of participants who reduce their transfusion requirement by ≥50%, as compared to baseline, over any rolling 12-week period during treatment. (Phase 1b and 2)

    Participants who are TD and achieve a reduction in transfusion requirement ≥50% as compared to baseline over any rolling 12-week period during treatment will be considered to have a minor response to treatment.

    Time frame: From Day 1 to the end of treatment on Day 169

  26. nTD participants will be evaluated for longest duration of mean Hgb increase of ≥1.5 g/dL from baseline during the treatment period (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  27. Mean change in Hgb over 12-week treatment periods will be evaluated for all cohorts (nTD, TD low, and TD high) (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  28. Maximum duration of RBC-transfusion-independent response for TD participants (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  29. Proportion of participants that require dose escalation in each cohort (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  30. Proportion of participants that improve Functional Assessment of Cancer Therapy-Anemia (FACT-An) subscale by at least 3 points in each cohort during the treatment period (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  31. Mean hemoglobin increase of ≥1.5 g/dL over any rolling 12-week interval and an increase in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue of 3 points by the end of study (EOS) for nTD participants (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  32. TD high cohort will be evaluated for absence of packed red blood cell (PRBC) transfusions a terminal 12-week interval during the treatment period with a minimum hemoglobin (Hgb) of 7 g/dL (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  33. TD low cohort: will be evaluated for the absence of PRBC transfusions a terminal 16-week interval during the treatment period with a minimum Hgb of 7 g/dL (Phase 1b and 2)

    Time frame: From Day 1 to the end of treatment on Day 169

  34. Non-transfusion-dependent (nTD) cohort will be evaluated for anemia response (Phase 1b and 2)

    Defined as the composite of the absence of transfusions over any rolling 12-week period and a concomitant mean Hgb increase of ≥1.5 g/dL over baseline

    Time frame: From Day 1 to the end of treatment on Day 169

  35. Safety and Tolerability of DISC-0974 (Phase 2 only)

    Assessed by treatment-emergent adverse events

    Time frame: From Day 1 to the end of treatment on Day 169

  36. Safety and Tolerability of DISC-0974 (Phase 2 only)

    Assessed by vital signs through blood pressure (mmHg), heart rate (bpm), respiration rate (breaths/min), and temperature (°C)

    Time frame: From Day 1 to the end of treatment on Day 169

  37. Safety and Tolerability of DISC-0974 (Phase 2 only)

    Assessed by physical examinations

    Time frame: From Day 1 to the end of treatment on Day 169

  38. Safety and Tolerability of DISC-0974 (Phase 2 only)

    Assessed by electrocardiogram (ECG) parameters: heart rate, PR interval, QRS duration, QRS axis, QT interval, and QTcF interval)

    Time frame: From Day 1 to the end of treatment on Day 169

  39. Safety and Tolerability of DISC-0974 assessed through blood testing (Phase 2 only)

    The blood testing will include a hematology panel, blood chemistry panel, serology/virology panel, biomarker assessments, PK assessments, and Anti-Drug Antibodies

    Time frame: From Day 1 to the end of treatment on Day 169

  40. Safety and Tolerability of DISC-0974 assessed through urine testing (Phase 2 only)

    The urine testing will include a urinalysis

    Time frame: From Day 1 to the end of treatment on Day 169

  41. Safety and tolerability of DISC-0974 following repeated SC doses in participants with MF receiving concomitant momelotinib or pacritinib therapy (Phase 2 only)

    Assessed by treatment-emergent adverse events

    Time frame: From Day 1 to the end of treatment on Day 169

  42. Safety and tolerability of DISC-0974 following repeated SC doses in participants with MF receiving concomitant momelotinib or pacritinib therapy (Phase 2 only)

    Assessed by vital signs through blood pressure (mmHg), heart rate (bpm), respiration rate (breaths/min), and temperature (°C)

    Time frame: From Day 1 to the end of treatment on Day 169

  43. Safety and tolerability of DISC-0974 following repeated SC doses in participants with MF receiving concomitant momelotinib or pacritinib therapy (Phase 2 only)

    Assessed by physical examinations

    Time frame: From Day 1 to the end of treatment on Day 169

  44. Safety and tolerability of DISC-0974 following repeated SC doses in participants with MF receiving concomitant momelotinib or pacritinib therapy (Phase 2 only)

    Assessed by electrocardiogram (ECG) parameters: heart rate, PR interval, QRS duration, QRS axis, QT interval, and QTcF interval)

    Time frame: From Day 1 to the end of treatment on Day 169

  45. Safety and tolerability of DISC-0974 following repeated SC doses in participants with MF receiving concomitant momelotinib or pacritinib therapy assessed through blood testing (Phase 2 only)

    The blood testing will include a hematology panel, blood chemistry panel, serology/virology panel, biomarker assessments, PK assessments, and Anti-Drug Antibodies

    Time frame: From Day 1 to the end of treatment on Day 169

  46. Safety and tolerability of DISC-0974 following repeated SC doses in participants with MF receiving concomitant momelotinib or pacritinib therapy assessed through urine testing (Phase 2 only)

    The urine testing will include a urinalysis

    Time frame: From Day 1 to the end of treatment on Day 169

Other outcomes

  1. Cmax (Phase 1b, 2, and Exploratory Cohorts)

    Maximum drug concentration (observed). Will be determined from blood PK sampling if appropriate data are available

    Time frame: From Day 1 to the end of treatment on Day 169

  2. Tmax (Phase 1b, 2, and Exploratory Cohorts)

    Observed time of the maximum drug concentration. Will be determined from blood PK sampling if appropriate data are available

    Time frame: From Day 1 to the end of treatment on Day 169

  3. AUC (Phase 1b, 2, and Exploratory Cohorts)

    Area under the drug concentration-time curve calculated using linear trapezoidal summation from time zero to 29 days following the first dose. Will be determined from blood PK sampling if appropriate data are available.

    Time frame: From Day 0 to 29 days after the first dose

07

Study locations

33 of 35 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2022 (actual). Primary completion is estimated for May 2027, 59 months after the start.

Of 26 phase 1/2 interventional studies under Primary Myelofibrosis, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 52 and three quarters within 125. This study's planned 59 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2022
First posted
Apr 11, 2022
StartActual
Jun 6, 2022
Primary completionEst.
May 2027
CompletionEst.
Jun 2027
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
3 sites added
Show 3 added (3 United States)
  • Northwest Oncology · Rolling Meadows, United States
  • University of Iowa · Iowa City, United States
  • Baylor Scott & White · Temple, United States
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    3 sites added
    Show 3 added (3 United States)
    • Northwest Oncology · Rolling Meadows, United States
    • University of Iowa · Iowa City, United States
    • Baylor Scott & White · Temple, United States

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05320198
Lead sponsor
Disc Medicine, Inc
Responsible party
Sponsor
First posted
Apr 11, 2022
Start date
Jun 6, 2022
Primary completion
May 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 22, 2026

Study contacts

Disc Medicine Clinical Trials
Contact
clinicaltrials@discmedicine.com
(617) 674 9274
Will Savage, MD PhD
study director · Disc Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Selcodebart

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