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

Recruiting now · Phase 1

Conditions studied: Polycythemia Vera (PV), Myelofibrosis (MF), Myeloproliferative Neoplasms (MPNs), Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Primary Myelofibrosis (PMF)

In brief

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).

Key facts

Study ID: NCT07469891
Run by: Prelude Therapeutics
People needed: 100
Starts: 2026-04-29
Expected to finish: 2028-04-01
Last updated by the study team: 2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures.
Confirmed diagnosis of PV or MF according to WHO 2016 or revised ICC/WHO 2022 criteria
Documented presence of a JAK2 V617 mutation
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Estimate life expectancy of ≥12 weeks per investigator assessment.
Negative serum or urine pregnancy test and agree to use contraception or maintain true abstinence.
Adequate organ function and bone marrow reserves (hematology, renal, and hepatic)

You may not qualify if…

History of another malignancy within 3 years prior to enrollment, except for malignancy considered cured with low risk of recurrence.
Clinically significant anemia due to nutritional deficiency or hemolytic disorders.
Active or uncontrolled infection requiring systemic therapy or hospitalization.
Any other medical or psychiatric conditions that, in the Investigator's judgment, would increase risk or interfere with study participation or interpretation of results.
Clinically significant or uncontrolled medical conditions, including active infection or cardiovascular disease, that would increase risk or interfere with study participation.
Unresolved toxicity > Grade 1 from prior anticancer therapy, except for alopecia or peripheral neuropathy ≤ Grade 2.
Pregnancy or breastfeeding
Known sensitivity or contraindication to any component of study, or the excipients of study treatment.
Prior systemic therapy for PV or MF, prior or planned allogeneic hematopoietic stem-cell transplantation, recent major surgery, prior splenectomy or prior splenic irradiation, or use of hematopoietic growth factors within protocol-defined washout periods.
Use of strong or moderate cytochrome P450 (CYP) 3A4 inhibitor or inducer, sensitive CYP3A substrates with narrow therapeutic range, or acid-reducing agents that cannot be discontinued prior to study treatment.
Participation in another interventional clinical study.

Where it is running

Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
BRCR Global - Coral Springs — Coral Springs, Florida, United States (enrolling)
Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
START Midwest, LLC — Grand Rapids, Michigan, United States (enrolling)
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office — Philadelphia, Pennsylvania, United States (enrolling)
Tennessee Oncology, PLLC - Investigational Drug Services — Nashville, Tennessee, United States (enrolling)
Tristar BMT — Nashville, Tennessee, United States (enrolling)
The University of Texas, MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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