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
Disc Medicine, Inc
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 informed consent form (ICF). 2. For Phase 1b: 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 biopsy report, according to WHO 2016 criteria.55 For Phase 2: In addition to the criteria above, DIPSS score of ≥2 (intermediate 1 risk) may also be included. 3. Washout of at least 28 days prior to Screeni…
Interventions
- DrugDISC-0974
DISC-0974 is administered subcutaneously.
Locations (24)
- City of Hope - DuarteDuarte, California
- City of Hope - LennarIrvine, California
- University of Colorado Anschutz Medical CampusAurora, Colorado
- Mayo Clinic JacksonvilleJacksonville, Florida
- Sylvester Cancer Center - U MiamiMiami, Florida
- Moffitt Cancer CenterTampa, Florida