Clinical Trial

A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms

Recruiting Phase 1
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Summary
This is a first-in-human, open-label, multi-center Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PRT12396 in participants with high-risk polycythemia vera (PV) and myelofibrosis (MF), and to determine the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE\[s\]). The study consists of a dose-escalation phase followed by a dose-expansion phase to further evaluate selected dose level(s).
Protocol Amendment History 2 changes
notable Trial sites expanded: 5 -> 8 locations 2026-08-01
critical Recruitment opened 2026-04-01
Trial Details
NCT Number NCT07469891
Lead Sponsor Prelude Therapeutics
Conditions Polycythemia Vera (PV), Myelofibrosis (MF), Myeloproliferative Neoplasms (MPNs), Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Primary Myelofibrosis (PMF)
Enrollment 100 participants
Start Date 2026-04-29
Primary Completion 2028-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-31