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RECRUITING
NCT07849231
PHASE1

A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms

Sponsor: Damora Therapeutics

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2026-09

Completion Date

2030-06

Last Updated

2026-10-07

Healthy Volunteers

No

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.

Locations (4)

Site AU08

Liverpool, New South Wales, Australia

Site AU09

Sydney, New South Wales, Australia

Site AU06

Melbourne, Victoria, Australia

Site AU03

Melbourne, Victoria, Australia