DMR-001 alone or with ruxolitinib for CALR-mutant myeloproliferative neoplasms
Tests DMR-001, alone or with ruxolitinib, in adults with CALR-mutant myeloproliferative neoplasms.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms
Key facts
- Where
- Adelaide, Brisbane, Liverpool, Melbourne, Newcastle, Perth, Sunshine Coast, and Sydney, AustraliaSee the 11 sites
- Phase
- Phase 1
Where in Australia
- AdelaideAdelaide, AustraliaNot yet recruiting
- BrisbaneBrisbane, AustraliaNot yet recruiting
- LiverpoolLiverpool, AustraliaNot yet recruiting
- MelbourneMelbourne, AustraliaTaking people
- MelbourneMelbourne, AustraliaTaking people
- MelbourneMelbourne, AustraliaNot yet recruiting
- NewcastleNewcastle, AustraliaNot yet recruiting
- PerthPerth, AustraliaNot yet recruiting
- Sunshine CoastSunshine Coast, AustraliaNot yet recruiting
- SydneySydney, AustraliaTaking people
- SydneySydney, AustraliaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Damora Therapeutics
- Trial code
- NCT07849231
- Record updated
- 27 October 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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: History of major bleeding or thrombosis within the last 3 months prior to study enrollment; Presence of any malignancy unless participant has been disease free for at least 2 years; 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; Prior hematopoietic stem cell transplantation or donor leukocyte infusion, or such transplantation or infusion is planned; Participants with laboratory values exceeding protocol defined thresholds.