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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
2026-10-07
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 (4)
Site AU08
Liverpool, New South Wales, Australia
Site AU09
Sydney, New South Wales, Australia
Site AU06
Melbourne, Victoria, Australia
Site AU03
Melbourne, Victoria, Australia