[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586015":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":52,"collaborators":32,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":32,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":32,"studyType":67,"phases":68,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":37,"whyStopped":32,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Haihe Biopharma Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation and expansion study of HH2853","EXPERIMENTAL","To determine the RP2D of HH2853 in PTCL patients.",[13],"Drug: HH2853 Tablets",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","HH2853 Tablets","25mg, 100mg and 200 mg BID oral administration",[9],[21],"HH2853",[23],{"name":24,"affiliation":25,"role":26},"Tongyu Li, MD","Sichuan Cancer Hospital and Research Institute","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Haiying Jia","CONTACT","86-20568888",null,"haiying.jia@haihepharma.com",[35],{"facility":36,"status":37,"city":38,"state":38,"zip":32,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Sichuan Cancer Hospital","RECRUITING","Chengdu","China","CN",{"type":42,"coordinates":43},"Point",[44,45],104.06667,30.66667,{"lat":45,"lon":44},[48],{"name":49,"role":30,"phone":50,"phoneExt":32,"email":51},"Huangming Hong, MD","86-13570431657","honghm3@mail.sysu.edu.cn",{"type":53,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100586015","phase-1-study-to-evaluate-efficacy-and-safety-of-hh2853-in-relapsedrefractory-peripheral-t-cell-lymphoma-100586015",false,"NCT06909877","Study to Evaluate Efficacy and Safety of HH2853 in Relapsed\u002FRefractory Peripheral T-cell Lymphoma","An Open-label, Multinational, Multicenter, Single-arm Phase Ⅰb\u002FⅡ Study to Evaluate Efficacy and Safety of Oral HH2853, a Selective EZH1\u002F2 Inhibitor, in Patients With Relapsed\u002FRefractory Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n* main inclusion:\n\n  1. Tumor types and prior antitumor therapy: Phase Ib:Dose Escalation: All enrolled patients must have histologically confirmed diagnosis NHL who have received at least one line of prior systematic treatment (and ≤ 5 lines) and relapses or refractory. Phase Ib dose expansion part: All enrolled patients must have histologically confirmed diagnosis of PTCL, including subtypes: PTCL-NOS, AITL, ALK + ALCL, ALK-ALCL, NKTCL, enteropathy associated T-cell lymphoma (EATL), monomorphic epitheliotropic internal T-cell lymphoma (MEITL), Hepatosplenic T-cell lymphoma (HSTCL), follicular T-cell lymphoma (FTCL), Nodal peripheral T-cell lymphoma with TFH phenotype (Nodal PTCL-TFH) and other invasive T-cell sources NHL at the investigator and sponsor's discretion (except highly invasive). All enrolled patients had relapsed or refractory diseases after receiving 1-line systematic treatment (≤ 3 lines). Phase II: All enrolled patients must have histologically confirmed diagnosis of PTCL, including subtypes: PTCL-NOS, AITL, ALK+ALCL, ALK-ALCL, NKTCL, EATL, MEITL, HSTCL, FTCL, Nodal PTCL-TFH et al. Patients must have histologically confirmed diagnosis of R\u002FR PTCL who have received at least one line of prior systematic combination chemotherapy and at least one new drug therapy (prior antitumor treatment lines ≤4 lines) : relapse and\u002For refractory.\n  2. Availability of qualified tissue samples by patient for pathological diagnosis by the central laboratory.\n  3. The Eastern cooperative oncology group (ECOG) score 0-1.\n  4. Life expectancy ≥ 3 months before starting HH2853 treatment.\n  5. Sufficient bone marrow, liver and renal functions.\n\nExclusion Criteria:\n\n* main criteria:\n\n  1. Previous treatment with EZH2 or EZH1\u002F2 inhibitors.\n  2. Central nervous system invasion.\n  3. Any previous history of bone marrow malignancy, including myelodysplastic syndrome (MDS).\n  4. Received medications that are known potent CYP3A4 inducers\u002Finhibitors within 1 week prior to first dose.","ALL","18 Years","75 Years",{"count":65,"type":66},100,"ESTIMATED","INTERVENTIONAL",[69,70],"PHASE1","PHASE2","This study is a an open-label, multinational, multicenter, single-arm Phase Ⅰb\u002FⅡ Study to Evaluate Efficacy and Safety of Oral HH2853 in Patients with Relapsed\u002FRefractory Peripheral T-cell Lymphoma.",[73],"Relapsed\u002FRefractory Peripheral T-Cell Lymphoma (R\u002FR PTCL)",[75,76],"Relapsed\u002FRefractory","Peripheral T-cell Lymphoma","2026-01-28",{"date":79,"type":80},"2026-01-30","ACTUAL",{"date":82,"type":80},"2022-07-27",{"date":84,"type":66},"2027-07-30",{"name":5,"class":6},1]