NCT07849231 · Damora Therapeutics
A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms
(CLARITY-101)
What this study is about
This is a multi-center, where both patients and doctors know the treatment given, Phase 1/1b study designed to evaluate the safety, how the drug moves through the body, immunogenicity, and preliminary effectiveness of DMR-001 treatment given alone 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.
View original scientific 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.
Interventions
DRUG
DMR-001
DMR-001 will be administered at protocol defined dose at a frequency of every 4 weeks.
DRUG
Ruxolitinib
Ruxolitinib will be administered according to Prescribing Information/SmPC.
Primary outcome measures
To evaluate the safety and tolerability of DMR-001 & determine the MTD, RDE(s), and/or recommended Phase 2 dose(s) in participants with CALR-mutant MPNs, when administered as monotherapy or in combination with ruxolitinib
Time frame: Up to 672 days
Incidence and severity of AEs and SAEs, including DLTs and AEs resulting in dose modification (interruption, reduction, or discontinuation)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
- Gilbert, Arizona
- Duarte, California
- Irvine, California
- Tampa, Florida
- Atlanta, Georgia
- Kansas City, Kansas
- Baltimore, Maryland
- Boston, Massachusetts
- Ann Arbor, Michigan
- St Louis, Missouri
- Babylon, New York
And 11 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 27, 2026 · Source of record for eligibility and locations