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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.

CaliforniaUCLA Ronald Reagan Medical Center, Los Angeles
University of California, Davis Comprehensive Cancer Center, Sacramento
ColoradoColorado Blood Cancer Institute, Denver
FloridaBRCR Global - Coral Springs, Coral Springs
Sylvester Comprehensive Cancer Center, Miami
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 Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.