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Phase 1 Study of PRT12396 for Myeloproliferative Neoplasms

This is a Phase 1 study testing a new oral capsule called PRT12396 for people with certain myeloproliferative neoplasms (MPNs), including polycythemia vera (PV) and myelofibrosis (MF). The main goals are to understand the safety of PRT12396, how well your body handles it, and to find the best dose. We'll also look for early signs of how well it works. To join, you need a confirmed diagnosis of PV or MF and a specific gene change called JAK2 V617 mutation. The study will track side effects and how they might lead to changes in your treatment over an average of two years.

Study design
This is a first-in-human, open-label (meaning you and the study team will know what treatment you are receiving) study. It will enroll up to 100 participants in two parts: a dose-escalation phase to find the right dose, followed by a dose-expansion phase.
What's involved
You will need to be willing and able to attend all scheduled visits, follow the treatment plan, and complete required laboratory tests and other study procedures. PRT12396 is taken as an oral capsule twice daily.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored through study completion, which is an average of two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07469891

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Prelude Therapeutics
~100 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:PRT12396

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicity (DLT) of PRT12396
Measured over Through cycle 1 (4 weeks)
+3 more outcomes measured

Conditions

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

Explore related trials

MyelofibrosisPolycythemia VeraJAK2 Gene

Where it's being run

8 sites across 6 states
Florida2
Tennessee2
Colorado1
Michigan1
Pennsylvania1
Texas1

Who to contact

Study Contact (Please Do Not Disclose Personal Information)
[email protected]
See Email
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Do you actually qualify for this trial?

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Eligibility criteria

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 0-2
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)

Exclusion

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.

What this trial measures

  • Dose limiting toxicity (DLT) of PRT12396Through cycle 1 (4 weeks)

    Incidence of dose limiting toxicities, defined according to protocol-specified criteria

  • Incidence and severity of Adverse eventsThrough study completion, an average of 2 years

    Incidence and severity of treatment-emergent adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 6.0

  • Adverse Events Leading to Dose Modifications or DiscontinuationThrough study completion, an average of 2 years

    Incidence of AEs leading to dose reductions, dose interruptions, treatment discontinuations, and clinically significant laboratory abnormalities

  • Maximum tolerated dose (MTD) and Recommended Dose(s) for Expansion (RDE[s]) of PRT12396Through study completion, an average of 2 years

    Determination of the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE\[s\]) based on evaluation of DLTs, safety, and tolerability data