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OncoMatch/Clinical Trials/NCT05320198

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

Is NCT05320198 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies DISC-0974 for myelofibrosis; anemia.

Phase 1/2RecruitingDisc Medicine, IncNCT05320198Data as of Sep 2026Location: United States · Australia

Treatment: DISC-0974This 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.

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Extracted eligibility criteria

Treatments studied

Other

DISC-0974

Cancer type

Myeloproliferative Neoplasm

Myelodysplastic Syndrome

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: hypomethylating agent or AML-like combination chemotherapy

Current treatment with hypomethylating agent or other acute myeloid leukemia (AML)-like combination chemotherapy or planned use within 6 months after Screening

Cannot have received: anemia-directed therapies (luspatercept, sotatercept, EPO-stimulating agent, imetelstat)

Exception: unless otherwise approved by Sponsor

Prior treatment with >3 anemia-directed therapies (unless otherwise approved by Sponsor) including: Luspatercept, Sotatercept (ACE-011), EPO-stimulating agent, Imetelstat

Lab requirements

Blood counts

Platelet count ≥25,000/µL and <1,000,000/µL; neutrophils ≥1,000/µL; total WBC count <50,000/µL at Screening

Kidney function

Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 by CKD-EPI formula

Liver function

AST and ALT <3.0x upper limit of normal (ULN) at Screening; Direct bilirubin <2x ULN at Screening. Higher levels are acceptable if attributed to ineffective erythropoiesis or Gilbert's syndrome, with approval from Sponsor.

Platelet count ≥25,000/µL and <1,000,000/µL; neutrophils ≥1,000/µL; total WBC count <50,000/µL at Screening. eGFR ≥30 mL/min/1.73 m2 by CKD-EPI formula. AST and ALT <3.0x ULN at Screening. Direct bilirubin <2x ULN at Screening.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Banner MD Anderson · Gilbert, Arizona
  • City of Hope - Duarte · Duarte, California
  • City of Hope - Lennar · Irvine, California
  • University of California, San Francisco · San Francisco, California
  • University of Colorado Anschutz Medical Campus · Aurora, Colorado

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05320198 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior hypomethylating agent or AML-like combination chemotherapy, anemia-directed therapies disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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