PRT12396 for Polycythemia Vera and Myelofibrosis, Two Rare Blood Cancers
Tests PRT12396 for safety and dosing in adults with polycythemia vera or myelofibrosis.
Plain-language title generated from the registry record
Registry title: A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
Key facts
- Where
- Adelaide, Clayton, and Nedlands, AustraliaSee the 3 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with polycythemia vera or myelofibrosis who have the JAK2 V617 mutation and have not yet had systemic treatment for it.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Confirmed polycythemia vera (PV) or myelofibrosis (MF) by WHO 2016 or revised ICC/WHO 2022 criteria. The study focuses on high-risk PV and MF.
- Earlier treatment
- No earlier systemic treatment for PV or MF. No earlier or planned donor stem-cell transplant. No earlier spleen removal or spleen radiation.
- Biomarker or test result
- A documented JAK2 V617 mutation.
Main reasons for not taking part
- Another cancer within the last 3 years, unless it has a low risk of coming back
- Active or uncontrolled infection needing systemic treatment or hospital care
- Pregnancy or breastfeeding
- Unresolved side effects above Grade 1 from earlier cancer treatment
- Taking another interventional clinical study treatment
Read by machine on 9 November 2026.
Where in Australia
- Royal Adelaide HospitalAdelaide, AustraliaTaking people
- Monash Health (Monash Medical Centre)Clayton, AustraliaTaking people
- One Clinical ResearchNedlands, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Prelude Therapeutics Incorporated
- Trial code
- NCT07469891EU 2026-525484-40-00
- Record updated
- 29 October 2026
- Original description
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).Read full original descriptionShow less
A Phase 1, Open-Label, Multi-Center, Safety and Efficacy Study of PRT12396 in Participants With Polycythemia Vera and Myelofibrosis
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).
Inclusion: 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: Unresolved toxicity Grade >1 from prior anticancer therapy, except for alopecia or peripheral neuropathy Grade ≤2; 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; 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; Pregnancy or breastfeeding; Known sensitivity or contraindication to any component of study, or the excipients of study treatment; Participation in another interventional clinical study.