Clinical trial · Interventional
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Mutant Calreticulin Targeted Antibodies in 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
- Retrieved
- Oct 1, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20261001-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloproliferative Neoplasms (MPNs) | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DMR-001 | Drug | — | UNRESOLVED |
| Ruxolitinib | Drug | Ruxolitinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1: DMR-001 monotherapy dose escalation phase.
- description
- 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.
- interventionNames
- Drug: DMR-001
- type
- EXPERIMENTAL
- label
- Part 2: DMR-001 monotherapy dose expansion phase.
- description
- 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.
- interventionNames
- Drug: DMR-001
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available