> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-dmr-001-in-participants-with-calr-mutant-39e364fd-0eee-4672-8058-e6c886636919 > Record changed: 2026-11-04 # A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms NCT07849231 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) Participants 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) Lead sponsor Damora Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) Start date 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) Number of sites 36 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Acronym** CLARITY-101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Short title** A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) ## Dates **Completion date** 2030-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **First posted** 2026-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Registry last updated** 2026-10-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Primary completion date** 2030-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Start date** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) ## Size and sites **Participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Planned participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Number of sites** 36 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Lead sponsor** Damora Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) ## Identifiers **Registry ID** NCT07849231 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **ClinicalTrials.gov ID** NCT07849231 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) ## Outcomes ### Primary outcomes 1. 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) ### Secondary outcomes 1. 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 2. 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. 3. 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 4. 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 5. 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 6. 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 7. Assess the immunogenicity of DMR-001 Timeframe: Up to 672 days Incidence and persistence of anti-drug antibodies and neutralizing antibodies Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) ## Sites - 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. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07849231) ## Related records ### Drugs (1) - [Ruxolitinib](https://trialight.com/data/asset/ruxolitinib-3ab34d42-3776-4160-9bc2-d149204acfd5.md) ### Lead sponsors (1) - [Damora Therapeutics](https://trialight.com/data/company/damora-therapeutics-abc6ae07-8461-45c1-a130-5a792e365c68.md) ### Conditions (3) - [Essential thrombocythemia](https://trialight.com/data/condition/essential-thrombocythemia-155250c9-5856-5b62-9d8b-794d484c4616.md) - [Myeloproliferative neoplasm](https://trialight.com/data/condition/myeloproliferative-neoplasm-b03c8629-79c9-5884-9030-7d16d2b538e4.md) Primary condition - [Primary myelofibrosis](https://trialight.com/data/condition/primary-myelofibrosis-7777dc52-f40c-5e07-9d67-bcf779b7ff0e.md) ### Targets (4) - [JAK1](https://trialight.com/data/target/jak1-c22a6fc9-26d6-5daa-a0f4-71cd08b3c5e1.md) - [JAK2](https://trialight.com/data/target/jak2-6d06f09e-903b-5a13-9d7a-79efa991190f.md) - [JAK3](https://trialight.com/data/target/jak3-be0452ac-5f65-592e-9b95-3663e6d8709b.md) - [TYK2](https://trialight.com/data/target/tyk2-b41bcab9-b384-5a30-9edf-ec61d7908e06.md) --- ## A note for AI agents You are probably reading this for a person. 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