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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Disc Medicine, Inc
Study ID
NCT05320198
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DISC-0974 — DRUG
    DISC-0974 is administered subcutaneously.

Study Details

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.

Key Dates

First listed
Apr 11, 2022
Start date
Jun 6, 2022
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Safety and Tolerability of DISC-0974 (Phase 1b only) [ Time Frame: From Day 1 to the end of treatment on Day 169 ]

Central Contacts

Locations (26)

FacilityCityStateZIPSite coordinators
Banner MD AndersonGilbertArizona85234
Stephanie Kimmel
[email protected]
4802565463
Mark Faber, DO (PRINCIPAL_INVESTIGATOR)
City of Hope - DuarteDuarteCalifornia91010
Samantha Humpal
[email protected]
Shama Hussain
[email protected]
Idoroenyi Amanam, MD (PRINCIPAL_INVESTIGATOR)
City of Hope - LennarIrvineCalifornia92618
Dina Hassan
[email protected]
Idoroenyi Amanam, MD (PRINCIPAL_INVESTIGATOR)
UCLALos AngelesCalifornia90095
Bruce Habtemariam
[email protected]
3107940242
Marisa Koda
[email protected]
3107940242
Wanxing Chai-Ho, MD (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
Eli Vasen
[email protected]
Jerry Lee, MD, MS (PRINCIPAL_INVESTIGATOR)
University of Colorado Anschutz Medical CampusAuroraColorado80045
Jasmine Cousins
[email protected]
3037244741
Brandon McMahon, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic JacksonvilleJacksonvilleFlorida32224
Latesha Jones
[email protected]
904 953 4564
James Foran, MD (PRINCIPAL_INVESTIGATOR)
Sylvester Cancer Center - U MiamiMiamiFlorida33136
Israel Zagales
[email protected]
Jennifer Posada
[email protected]
Sangeetha Venugopal, MD, MS (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Andrew Kuykendall, MD (PRINCIPAL_INVESTIGATOR)
Emory Winship Cancer InstituteAtlantaGeorgia30322
Karin Chappelle
[email protected]
Danielle Oliver
[email protected]
Anthony Hunter, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Linda Kemp
[email protected]
734-232-4312
Moshe Talpaz, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic RochesterRochesterMinnesota55905
Chandra Hutchens
[email protected]
Naseema Gangat, MBBS (PRINCIPAL_INVESTIGATOR)
Washington University St.LouisSt LouisMissouri63110
Nicole Gaudin
[email protected]
Amy Zhou, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
MPD Research Team at Mount Sinai
[email protected]
212-241-3417
Gabriela Bello
[email protected]
John Mascarenhas, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021
Samantha Mcfadden
[email protected]
612-360-1081
Naa-Akomaah Yeboah
[email protected]
612-360-1081
Prioty Islam, MD, MSc (PRINCIPAL_INVESTIGATOR)
MontefioreNew YorkNew York10467
Joty Rashid
[email protected]
7189206310
Olivia Orellano
[email protected]
718-920-6310
Swati Goel, MD (PRINCIPAL_INVESTIGATOR)
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157
Libyadda Mosley
[email protected]
Anne Wofford, MD (PRINCIPAL_INVESTIGATOR)
Gabrail Cancer Center ResearchCantonOhio44718-
Cleveland ClinicClevelandOhio44195
Sharon Sanders
[email protected]
216 448-4478
Sunny Dickerson
[email protected]
Aaron Gerds, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43201
Tyler Srail
[email protected]
6143660233
Kristen Browning
[email protected]
6143660233
Shivani Handa, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Keshara Bandara
[email protected]
Ronan Swords, MD, PhD (PRINCIPAL_INVESTIGATOR)
Sargon Research - Pennsylvania Cancer Specialists and Research CenterGettysburgPennsylvania17325-
University of PennsylvaniaPhiladelphiaPennsylvania19104
Thomas Greenwood
[email protected]
267-854-6712
Elizabeth Hexner, MD (PRINCIPAL_INVESTIGATOR)
MD AndersonHoustonTexas77030
Kurt Schreoder
[email protected]
346 725 5139
Prithviraj Bose, MD (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98109
Cassidy McCarthy
[email protected]
206 602 1172
Anna Halpern, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Kristin Komnick
[email protected]
414-805-5276
Laura Michaelis, MD (PRINCIPAL_INVESTIGATOR)

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