Myeloproliferative Neoplasms (MPNs)Phase 1CLARITY-101NCT07849231
A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms
A Phase 1 study testing DMR-001 and Ruxolitinib in people with Myeloproliferative Neoplasms (MPNs), run by Damora Therapeutics at 4 sites in Australia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasms (MPNs)
- What is being tested?
- DMR-001 and Ruxolitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 4 sitesAustralia
- Study dates
- Sep 2026to Jun 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia4 sites, 4 recruiting
- Not yet recruiting
Site AU08
Liverpool, New South Wales, 2170
- Not yet recruiting
Site AU06
Melbourne, Victoria, 2031
- Not yet recruiting
Site AU03
Melbourne, Victoria, 3004
- Recruiting
Site AU09
Sydney, New South Wales, 2050
About this study
Official title: 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.
- Conditions
- Myeloproliferative Neoplasms (MPNs)
- Being tested
- DMR-001, Ruxolitinib
- Keywords
- Myeloproliferative Neoplasms, Myelofibrosis, Essential Thrombocythemia, CALR mutation
- Medical subject headings
- Myeloproliferative Disorders, Primary Myelofibrosis, Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMR-001Drug
DMR-001 will be administered at protocol defined dose at a frequency of every 4 weeks.
RuxolitinibDrug
Also called Jakafi, Jakavi
Ruxolitinib will be administered according to Prescribing Information/SmPC.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: DMR-001 monotherapy dose escalation phase. | Experimental | DMR-001 will be administered starting once every 4 weeks as a subcutaneous injection at the protocol defined starting dose and dosing schedule to identify the maximum tolerated dose and/or recommended dose(s) for expansion. Receives: Drug: DMR-001 |
| Part 2: DMR-001 monotherapy dose expansion phase. | Experimental | DMR-001 will be administered starting once every 4 weeks as a subcutaneous injection at the determined recommended dose(s) for expansion based on Part 1. Receives: Drug: DMR-001 |
| Part 3: DMR-001 and ruxolitinib combination dose escalation followed by dose expansion. | Experimental | DMR-001 will be administered starting once every 4 weeks as a subcutaneous injection at the determined dose and regimen, but in combination with an oral tablet of ruxolitinib, a standard of care drug approved therapy for the treatment of MF. Receives: Drug: DMR-001; Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Incidence and severity of AEs and SAEs, including DLTs and AEs resulting in dose modification (interruption, reduction, or discontinuation)
Measured: Up to 672 days
Secondary outcomes (7)
Evaluate preliminary clinical activity of DMR-001 as a monotherapy in participants with CALR-mutant ET
Objective response rate based on MPN specific response criteria
Measured: Up to 672 days
Evaluate preliminary clinical activity of DMR-001 as a monotherapy or in combination with ruxolitinib in participants with CALR-mutant MF
Established by looking at overall response rate based on MPN specific response criteria, protocol defined spleen volume reduction and protocol defined anemia response.
Measured: Up to 672 days
Pharmacokinetics parameter: Cmax of DMR-001 when administered as monotherapy or in combination with ruxolitinib
Maximum observed plasma concentration of DMR-001 monotherapy or DMR-001 in combination with ruxolitinib
Measured: Up to 672 days
Pharmacokinetics parameter: Tmax of DMR-001 when administered as monotherapy or in combination with ruxolitinib
Time to reach the maximum concentration of DMR-001 monotherapy or DMR-001 in combination with ruxolitinib
Measured: Up to 672 days
Pharmacokinetics parameter: AUC(0-t) of DMR-001 when administered as monotherapy or in combination with ruxolitinib
Area under the concentration-time curve up to the last measurable concentration of DMR-001 monotherapy or DMR-001 in combination with ruxolitinib
Measured: Up to 672 days
Pharmacokinetics parameter: t1/2 of DMR-001 when administered as monotherapy or in combination with ruxolitinib
Apparent terminal phase disposition half-life of DMR-001 monotherapy or DMR-001 in combination with ruxolitinib
Measured: Up to 672 days
Assess the immunogenicity of DMR-001
Incidence and persistence of anti-drug antibodies and neutralizing antibodies
Measured: Up to 672 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative Neoplasms (MPNs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damora Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849231
- Sponsor's protocol ID
- DMRA-MPN-101
- Acronym
- CLARITY-101
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No