[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606839":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":22,"responsibleParty":29,"collaborators":22,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":22,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":22,"enrollmentInfo":40,"targetDuration":22,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":49,"overallStatus":53,"whyStopped":22,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":22},{"fullName":5,"class":6},"Boryung Pharmaceutical Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BR101801 (Bosmolisib)","EXPERIMENTAL","Patients will receive BR101801 capsules orally, QD in 28-day cycles",[13],"Drug: BR101801",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","BR101801","Patients will receive 200mg capsules (100mg+100mg)",[9],[21],"Bosmolisib",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Shinyoung Oh","CONTACT","+82 2-708-8000","syoh@boryung.co.kr",{"type":30,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100606839","phase-2-a-study-of-bosmolisib-br101801-in-participants-with-rr-ptcl-100606839",false,"NCT07180771","A Study of Bosmolisib (BR101801) in Participants With R\u002FR PTCL.","A Phase II, Single-arm, Multicenter, Open Label Study to Evaluate Efficacy and Safety of BR101801 Monotherapy in Relapsed\u002FRefractory Peripheral T-cell Lymphoma Patients","Key Inclusion Criteria:\n\n1. The ECOG performance status ≤ 2.\n2. Life expectancy more than 3 months.\n3. Patients with relapsed and\u002For refractory to standard therapy or are intolerance to standard therapy diagnosed with 2022 World Health Organization (WHO) classification\n\n   * Peripheral T-cell lymphoma, not otherwise specified\n   * Nodal TFH cell lymphoma, angioimmunoblastic-type\n   * Nodal TFH cell lymphoma, follicular-type\n   * Nodal TFH cell lymphoma, NOS\n4. Patients currently requiring systemic therapy at the investigator's discretion.\n5. Patients with a lesion measuring 1.5 cm or more in its longest transverse diameter, as determined by CT, PET\u002FCT or MRI scans according to the 2014 Lugano criteria.\n\nKey Exclusion Criteria:\n\n1. The presence of overt leptomeningeal or active central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks.\n2. Impaired cardiac function or clinically significant cardiac disease.\n3. Patients with interstitial pneumonia or history of drug-induced interstitial pneumonia\u002Fpneumonitis.\n4. For patients with lymphoma:\n\n   * Systemic antineoplastic therapy (including cytotoxic chemotherapy, alfa-interferon \\[INF\\], and toxin immunoconjugates) or any experimental therapy within 3 weeks or 5 half lives, whichever is shorter, before the first dose of study treatment.\n   * Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.\n   * Unconjugated monoclonal antibody therapies \\\u003C 6 weeks before the first dose of study treatment.\n5. Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (\\>20 mg\u002Fday prednisone or equivalent).","ALL","19 Years",{"count":41,"type":42},44,"ESTIMATED","INTERVENTIONAL",[45],"PHASE2","The objective of this phase II study is to evaluate the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma(PTCL).",[48],"Peripheral T Cell Lymphoma",[50,21,17,51,52],"PTCL","PI3K inhibitor","DNA-PK","NOT_YET_RECRUITING","2026-01-27",{"date":56,"type":57},"2026-01-28","ACTUAL",{"date":59,"type":42},"2026-02",{"date":61,"type":42},"2027-09",{"name":5,"class":6}]