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

A Phase 1/1b Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Mutant Calreticulin Targeted Antibodies, Administered Alone or in Combination With Ruxolitinib, in Participants With CALR-mutant Myeloproliferative Neoplasms

Who can join

Ages 18 and older · All sexes

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.

About the 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.

What is being tested

• DMR-001 (drug)
• Ruxolitinib (drug)

Sponsor: Damora Therapeutics · Participants: 250 · Started: 2026-09

Contact the study team

• Damora Therapeutics Medical Monitor · Phone: +1 782-281-9020

Official record on ClinicalTrials.gov — NCT07849231

Locations in the U.S.

Conditions

• Myeloproliferative Neoplasms
• Myelofibrosis
• Essential Thrombocythemia

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.