NCT07469891 A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
| NCT ID | NCT07469891 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Prelude Therapeutics |
| Condition | Polycythemia Vera (PV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-29 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2026-04-29 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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 0-2 * 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 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.
Contact & Investigator
Study Contact (Please Do Not Disclose Personal Information)
✉ clinicaltrials@preludetx.com📞 See Email
Frequently Asked Questions
Who can join the NCT07469891 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Polycythemia Vera (PV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07469891 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07469891 currently recruiting?
Yes, NCT07469891 is actively recruiting participants. Contact the research team at clinicaltrials@preludetx.com for enrollment information.
Where is the NCT07469891 trial being conducted?
This trial is being conducted at Denver, United States, Coral Springs, United States, Grand Rapids, United States, Philadelphia, United States and 1 additional location.
Who is sponsoring the NCT07469891 clinical trial?
NCT07469891 is sponsored by Prelude Therapeutics. The trial plans to enroll 100 participants.