[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642056":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":64,"collaborators":20,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":20,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":20,"enrollmentInfo":75,"targetDuration":20,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":20,"overallStatus":84,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-3079 Group","EXPERIMENTAL","SHR-3079.",[13],"Drug: SHR-3079 Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","SHR-3079 Injection","SHR-3079 injection.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Wei Ji, M.M","CONTACT","+86-0518-82342973","wei.ji.wj10@hengrui.com",[28,48],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Beijing Cancer Hospital","Beijing","Beijing Municipality","100142","China","CN",{"type":36,"coordinates":37},"Point",[38,39],116.39723,39.9075,{"lat":39,"lon":38},[42,46],{"name":43,"role":24,"phone":44,"phoneExt":20,"email":45},"Yuqin Song","8610-88196118","SongYQ22622@163.com",{"name":43,"role":47,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"facility":49,"status":20,"city":50,"state":51,"zip":52,"country":33,"countryCode":34,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060",{"type":36,"coordinates":54},[55,56],113.25,23.11667,{"lat":56,"lon":55},[59,63],{"name":60,"role":24,"phone":61,"phoneExt":20,"email":62},"Qingqing Cai","8620-87342823","caiqq@sysucc.org.cn",{"name":60,"role":47,"phone":20,"phoneExt":20,"email":20},{"type":65,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100642056","phase-1-a-clinical-study-of-shr-3079-in-b-cell-non-hodgkin-lymphoma-100642056",false,"NCT07661537","A Clinical Study of SHR-3079 in B-cell Non-Hodgkin Lymphoma","An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3079 Injection in Participants With B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Aged ≥ 18 years old;\n2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, expected survival ≥ 3 months;\n3. Histologically confirmed B-NHL;\n4. Participant population: Have received ≥ 1 line of standard anti-tumor treatment, and have not achieved response after the latest treatment or have progressive disease after the treatment;\n5. Have measurable lesions;\n6. Have adequate organ function;\n7. Male participants and female participants of childbearing potential must use adequate and effective contraceptive measures during the study and within 3 months after the last drug administration of SHR-3079. Female participants must not be lactating and must have a negative blood HCG test result within 7 days before the first dose;\n8. Voluntarily sign the ICF, have good compliance, and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Central nervous system (CNS) infiltration;\n2. Prior chemotherapy or other anti-lymphoma agents administered within 4 weeks before the first dose of study treatment;\n3. Major surgery within 4 weeks before signing the ICF, or plan to undergo major surgery during the study period;\n4. Receipt of CAR-T therapy or autologous stem cell transplant within 12 weeks prior to enrollment;\n5. Receipt of allogeneic hematopoietic stem cell transplantation;\n6. Prior solid organ transplantation;\n7. Positive hepatitis C virus (HCV) antibody with HCV-RNA copy number above the upper limit of normal of the study site; positive hepatitis B surface antigen \\[HBsAg\\] and\u002For positive hepatitis B core antibody (HBcAb) with HBV DNA copy number above the upper limit of normal of the study site;\n8. Presence of severe disorders involving major organ systems;\n9. Pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;\n10. Pregnant, lactating women, or women planning to become pregnant;\n11. Have other serious physical or mental illness, laboratory test abnormalities, or other factors that may increase the risk of study participation or interfere with the study results.","ALL","18 Years",{"count":76,"type":77},90,"ESTIMATED","INTERVENTIONAL",[80],"PHASE1","The study is being conducted to evaluate the safety and tolerability of SHR-3079, and to explore the Dose-limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of SHR-3079 in patients with B-cell non-Hodgkin lymphoma.",[83],"B-cell Non-Hodgkin Lymphoma","NOT_YET_RECRUITING","2026-06-16",{"date":87,"type":88},"2026-06-22","ACTUAL",{"date":90,"type":77},"2026-06",{"date":92,"type":77},"2028-12",{"name":5,"class":6},2]