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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Damora Therapeutics • ClinicalTrials.gov ID: NCT07849231

Registry updated: 2026-10-07
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Description

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.

Interventions

  • DMR-001 (Drug)
    DMR-001 will be administered at protocol defined dose at a frequency of every 4 weeks.
  • Ruxolitinib (Drug)
    Ruxolitinib will be administered according to Prescribing Information/SmPC.

Eligibility criteria

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.

Conditions

Myeloproliferative Neoplasms (MPNs)

Locations

  • Site AU08 — Liverpool, New South Wales, Australia
  • Site AU09 — Sydney, New South Wales, Australia
  • Site AU06 — Melbourne, Victoria, Australia
  • Site AU03 — Melbourne, Victoria, Australia
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record