RecruitingPhase 1NCT07469891

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

A Phase 1, Open-Label, Multi-Center, Safety and Efficacy Study of PRT12396 in Participants With Polycythemia Vera and Myelofibrosis

Sponsor

Prelude Therapeutics

Enrollment

100 participants

Start Date

Apr 29, 2026

Study Type

INTERVENTIONAL

Conditions

Primary myelofibrosis (PMF)Post-polycythemia Vera Myelofibrosis Post-essential Thrombocythemia Myelofibrosis Myelofibrosis (MF)Polycythemia Vera (PV)Myeloproliferative Neoplasms (MPNs)

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PRT12396 for people with myelofibrosis (mf), myeloproliferative neoplasms (mpns), and other related conditions. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPRT12396

PRT12396 is an investigational oral capsule administered twice daily at the assigned dose level or RDE. Capsules are swallowed whole with water and may be taken one hour before or two hours after meals.

Locations(5)

Colorado Blood Cancer Institute

Denver, Colorado, United States

BRCR Global - Coral Springs

Coral Springs, Florida, United States

START Midwest, LLC

Grand Rapids, Michigan, United States

Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office

Philadelphia, Pennsylvania, United States

Tristar BMT

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07469891

Related Trials

Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia

NCT0532019828 locations

A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)

NCT0735772730 locations

Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML)

NCT071283811 location

A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors

NCT0688780312 locations

A Clinical Study of Gecacitinib Combined With Pegylated Interferon in Patients With PV

NCT074458931 location