A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms
- 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 participants with CALR-mutant MF.
- Acronym
- CLARITY-101
- Short title
- A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2030-06-01
- First posted
- 2026-09-30
- Registry last updated
- 2026-10-27
- Primary completion date
- 2030-06-01
- Start date
- 2026-09-01
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Damora Therapeutics
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07849231
- ClinicalTrials.gov ID
- NCT07849231
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
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
Timeframe: Up to 672 days
Incidence and severity of AEs and SAEs, including DLTs and AEs resulting in dose modification (interruption, reduction, or discontinuation)
Evaluate preliminary clinical activity of DMR-001 as a monotherapy in participants with CALR-mutant ET
Timeframe: Up to 672 days
Objective response rate based on MPN specific response criteria
Evaluate preliminary clinical activity of DMR-001 as a monotherapy or in combination with ruxolitinib in participants with CALR-mutant MF
Timeframe: Up to 672 days
Established by looking at overall response rate based on MPN specific response criteria, protocol defined spleen volume reduction and protocol defined anemia response.
Pharmacokinetics parameter: Cmax of DMR-001 when administered as monotherapy or in combination with ruxolitinib
Timeframe: Up to 672 days
Maximum observed plasma concentration of DMR-001 monotherapy or DMR-001 in combination with ruxolitinib
Pharmacokinetics parameter: Tmax of DMR-001 when administered as monotherapy or in combination with ruxolitinib
Timeframe: Up to 672 days
Time to reach the maximum concentration of DMR-001 monotherapy or DMR-001 in combination with ruxolitinib
Pharmacokinetics parameter: AUC(0-t) of DMR-001 when administered as monotherapy or in combination with ruxolitinib
Timeframe: Up to 672 days
Area under the concentration-time curve up to the last measurable concentration of DMR-001 monotherapy or DMR-001 in combination with ruxolitinib
Pharmacokinetics parameter: t1/2 of DMR-001 when administered as monotherapy or in combination with ruxolitinib
Timeframe: Up to 672 days
Apparent terminal phase disposition half-life of DMR-001 monotherapy or DMR-001 in combination with ruxolitinib
Assess the immunogenicity of DMR-001
Timeframe: Up to 672 days
Incidence and persistence of anti-drug antibodies and neutralizing antibodies
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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.
- Site US07Birmingham, United StatesNot yet recruiting
- Site US26Gilbert, United StatesNot yet recruiting
- Site US11Duarte, United StatesNot yet recruiting
- Site US25Irvine, United StatesNot yet recruiting
- Site US04Tampa, United StatesNot yet recruiting
- Site US15Atlanta, United StatesNot yet recruiting
- Site US21Kansas City, United StatesNot yet recruiting
- Site US18Baltimore, United StatesNot yet recruiting
- Site US03Boston, United StatesNot yet recruiting
- Site US12Boston, United StatesNot yet recruiting
- Site US06Ann Arbor, United StatesNot yet recruiting
- Site US08St Louis, United StatesNot yet recruiting
- Site US17Babylon, United StatesNot yet recruiting
- Site US01New York, United StatesNot yet recruiting
- Site US02New York, United StatesNot yet recruiting
- Site US14Charlotte, United StatesNot yet recruiting
- Site US24Durham, United StatesNot yet recruiting
- Site US13Winston-Salem, United StatesNot yet recruiting
- Site US05Columbus, United StatesNot yet recruiting
- Site US20Eugene, United StatesNot yet recruiting
- Site US19Nashville, United StatesNot yet recruiting
- Site US10Houston, United StatesNot yet recruiting
- Site US16Salt Lake City, United StatesNot yet recruiting
- Site US23Richmond, United StatesNot yet recruiting
- Site US22Seattle, United StatesNot yet recruiting
And 11 more, listed on the interactive page.