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A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms
Sponsor: Damora Therapeutics
Summary
This is a multi-center, open-label, Phase 1/1b study designed to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of DMR-001 monotherapy in adult participants with CALR-mutated essential thrombocythemia (ET) and myelofibrosis (MF), and of DMR-001 in combination with ruxolitinib in participants with CALR-mutant MF.
Official title: A Phase 1/1b Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Mutant Calreticulin Targeted Antibodies, Administered Alone or in Combination With Ruxolitinib, in Participants With CALR-mutant Myeloproliferative Neoplasms
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2026-09
Completion Date
2030-06
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
DMR-001
DMR-001 will be administered at protocol defined dose at a frequency of every 4 weeks.
Ruxolitinib
Ruxolitinib will be administered according to Prescribing Information/SmPC.
Locations (36)
Site US07
Birmingham, Alabama, United States
Site US26
Gilbert, Arizona, United States
Site US11
Duarte, California, United States
Site US25
Irvine, California, United States
Site US04
Tampa, Florida, United States
Site US15
Atlanta, Georgia, United States
Site US21
Kansas City, Kansas, United States
Site US18
Baltimore, Maryland, United States
Site US03
Boston, Massachusetts, United States
Site US12
Boston, Massachusetts, United States
Site US06
Ann Arbor, Michigan, United States
Site US08
St Louis, Missouri, United States
Site US17
Babylon, New York, United States
Site US01
New York, New York, United States
Site US02
New York, New York, United States
Site US14
Charlotte, North Carolina, United States
Site US24
Durham, North Carolina, United States
Site US13
Winston-Salem, North Carolina, United States
Site US05
Columbus, Ohio, United States
Site US20
Eugene, Oregon, United States
Site US19
Nashville, Tennessee, United States
Site US10
Houston, Texas, United States
Site US16
Salt Lake City, Utah, United States
Site US23
Richmond, Virginia, United States
Site US22
Seattle, Washington, United States
Site AU08
Liverpool, New South Wales, Australia
Site AU07
Newcastle, New South Wales, Australia
Site AU06
Sydney, New South Wales, Australia
Site AU09
Sydney, New South Wales, Australia
Site AU11
Brisbane, Queensland, Australia
Site AU10
Sunshine Coast, Queensland, Australia
Site AU01
Adelaide, South Australia, Australia
Site AU02
Melbourne, Victoria, Australia
Site AU03
Melbourne, Victoria, Australia
Site AU04
Melbourne, Victoria, Australia
Site AU05
Perth, Western Australia, Australia