DMR-001 in CALR-mutant myeloproliferative neoplasms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, open-label Phase 1/1b trial evaluating the safety, pharmacokinetics, immunogenicity, and preliminary activity of DMR-001 as a single agent in CALR-mutant essential thrombocythemia and myelofibrosis, and in combination with ruxolitinib for CALR-mutant myelofibrosis. Adults with CALR exon-9 mutations and confirmed ET or MF may participate after informed consent. Participants may undergo bone marrow biopsy as part of assessments. Key safety and eligibility criteria guide enrollment, with primary focus on safety and early signals of efficacy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Site AU09
  Sydney, New South Wales, Australia Recruiting
• Site AU02
  Melbourne, Victoria, Australia Recruiting
• Site AU03
  Melbourne, Victoria, Australia Recruiting
• Site US07
  Birmingham, Alabama, United States Not yet recruiting
• Site US26
  Gilbert, Arizona, United States Not yet recruiting
• Site US11
  Duarte, California, United States Not yet recruiting

Study contacts

• Study coordinator: Damora Therapeutics Medical Monitor
• Email: ClinicalTrials@Damoratx.com
• Phone: +1 782-281-9020

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.