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A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms

RecruitingPhase 1Ages 18 Years - anyAllDamora Therapeutics
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and the protocol. * Diagnosis/confirmation of ET or MF as defined in the protocol. * Documented CALR exon-9 mutation. * Willingness to undergo bone marrow biopsy and aspiration per the Schedule of Assessments. Exclusion Criteria: * Presence of any malignancy unless participant has been disease free for at least 2 years. * History of major bleeding or thrombosis within the last 3 months prior to study enrollment. * Prior hematopoietic stem cell transplantation or donor leukocyte infusion, or such transplantation or infusion is planned. * Participants with laboratory values exceeding protocol defined thresholds. * History of clinically significant or uncontrolled cardiac disease. * Active HBV, HCV or HIV. * Known hypersensitivity to DMR-001 or ruxolitinib or any of their components. Other protocol defined Inclusion/Exclusion Criteria may apply.
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What it tests

  • DMR-001
  • Ruxolitinib
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Where

4 sites
Site AU08
Liverpool, Australia
Site AU09
Sydney, Australia
Site AU06
Melbourne, Australia
Site AU03
Melbourne, Australia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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