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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
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
- PRT12396 (drug)
Sponsor: Prelude Therapeutics Incorporated · Participants: 100 · Started: Apr 29, 2026
Contact the study team
- Study Contact (Please Do Not Disclose Personal Information) · Phone: See Email
Official record on ClinicalTrials.gov — NCT07469891
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.