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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 0-1
* 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)

Exclusion Criteria:

* 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.

About the study

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).

What is being tested

Sponsor: Prelude Therapeutics Incorporated · Participants: 100 · Started: Apr 29, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07469891

Locations in the U.S.

ColoradoColorado Blood Cancer Institute, Denver
FloridaBRCR Global - Coral Springs, Coral Springs
Moffitt Cancer Center, Tampa
MichiganSTART Midwest, LLC, Grand Rapids
PennsylvaniaThomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office, Philadelphia
TennesseeTennessee Oncology, PLLC - Investigational Drug Services, Nashville
Tristar BMT, Nashville
TexasThe University of Texas, MD Anderson Cancer Center, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.