RecruitingMyeloproliferative Neoplasms (MPNs)

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

Eligible age

18+ yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

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About this study

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.

Sponsor: Damora Therapeutics

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.