[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Prelude Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100629072","phase-1-a-phase-1-study-of-prt12396-in-participants-with-select-myeloproliferative-neoplasms-100629072",false,"NCT07469891","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","Inclusion Criteria:\n\n* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures.\n* Confirmed diagnosis of PV or MF according to WHO 2016 or revised ICC\u002FWHO 2022 criteria\n* Documented presence of a JAK2 V617 mutation\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Estimate life expectancy of ≥12 weeks per investigator assessment.\n* Negative serum or urine pregnancy test and agree to use contraception or maintain true abstinence.\n* Adequate organ function and bone marrow reserves (hematology, renal, and hepatic)\n\nExclusion Criteria:\n\n* History of another malignancy within 3 years prior to enrollment, except for malignancy considered cured with low risk of recurrence.\n* Clinically significant anemia due to nutritional deficiency or hemolytic disorders.\n* Active or uncontrolled infection requiring systemic therapy or hospitalization.\n* Any other medical or psychiatric conditions that, in the Investigator's judgment, would increase risk or interfere with study participation or interpretation of results.\n* Clinically significant or uncontrolled medical conditions, including active infection or cardiovascular disease, that would increase risk or interfere with study participation.\n* Unresolved toxicity \\> Grade 1 from prior anticancer therapy, except for alopecia or peripheral neuropathy ≤ Grade 2.\n* Pregnancy or breastfeeding\n* Known sensitivity or contraindication to any component of study, or the excipients of study treatment.\n* 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.\n* 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.\n* Participation in another interventional clinical study.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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).",[26,27,28,29,30,31],"Polycythemia Vera (PV)","Myelofibrosis (MF)","Myeloproliferative Neoplasms (MPNs)","Post-Polycythemia Vera Myelofibrosis","Post-Essential Thrombocythemia Myelofibrosis","Primary Myelofibrosis (PMF)",[33,34,35,36,37,38,39,40],"High-Risk Polycythemia Vera (PV)","Intermediate-1 or Intermediate-2 Risk Primary MF","High-Risk Primary MF","Post-Polycythemia Vera MF","Post-Essential Thrombocythemia MF","PRT12396","JAK Inhibitor","Myeloproliferative Neoplasms (MPN)","RECRUITING","2026-06-05",{"date":44,"type":45},"2026-06-09","ACTUAL",{"date":47,"type":45},"2026-04-29",{"date":49,"type":20},"2028-04",{"name":51,"class":52},"Prelude Therapeutics","INDUSTRY",5,""]