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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 9 → 18 locations
  2. Sponsor changed: Prelude Therapeutics to Prelude Therapeutics Incorporated Eligibility criteria expanded, about 16 words · Secondary endpoints: details revised at 3 of 17 entries · Study description revised Show 3 more changesShow less
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 3 of 17 entries
    • Study description revised
  3. Lead sponsor: Prelude Therapeutics to Prelude Therapeutics Incorporated Study sites: 8 to 9v8 Show 1 more changeShow less
    • Study sites: 8 to 9
  4. Trial sites expanded: 5 → 8 locationsv7
  5. Study sites: 3 to 5v6
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 2 to 3v5
  2. Study sites: 1 to 2v4
  3. Start date changed from estimate of Apr 2026 to Apr 29, 2026v3
  1. Recruitment opened Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07469891
Lead Sponsor Prelude Therapeutics Incorporated
Conditions Polycythemia Vera (PV), Myelofibrosis (MF), Myeloproliferative Neoplasms (MPNs), Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Primary Myelofibrosis (PMF)
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov