DMR-001 for Myelofibrosis
(CLARITY-101 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with essential thrombocythemia or myelofibrosis who have a specific CALR gene mutation. Participants must agree to bone marrow tests and sign consent forms.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- DMR-001
- Ruxolitinib
Trial Overview
The study is testing a new drug called DMR-001 alone in people with CALR-mutant ET or MF, and DMR-001 combined with ruxolitinib in those with CALR-mutant MF. The main focus is on safety and how the body handles the drug.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
DMR-001 will be administered starting once every 4 weeks as a subcutaneous injection at the determined dose and regimen, but in combination with an oral tablet of ruxolitinib, a standard of care drug approved therapy for the treatment of MF.
DMR-001 will be administered starting once every 4 weeks as a subcutaneous injection at the determined recommended dose(s) for expansion based on Part 1.
DMR-001 will be administered starting once every 4 weeks as a subcutaneous injection at the protocol defined starting dose and dosing schedule to identify the maximum tolerated dose and/or recommended dose(s) for expansion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Damora Therapeutics
Lead Sponsor
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