NCT07849231RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 21 Sept 2026
- Start date
- Sept 2026
- Primary completion date
- Jun 2030
- Lead sponsor
- Damora Therapeutics
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT07849231
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 250
- From Sept 2026 to the primary completion date, Jun 2030
- 36 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of major bleeding or thrombosis within the last 3 months prior to study enrollment.
Other illness
- 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.
Lab values
- Prior hematopoietic stem cell transplantation or donor leukocyte infusion, or such transplantation or infusion is planned.
- Participants with laboratory values exceeding protocol defined thresholds.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.