[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487200":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":34,"responsibleParty":77,"collaborators":79,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":20,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":20,"studyType":97,"phases":98,"briefSummary":101,"conditions":102,"keywords":20,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study treatment","EXPERIMENTAL","Participants receive GNC-038 as intravenous infusion for the first cycle (2 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.",[13],"Drug: GNC-038",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","GNC-038","Administration by intravenous infusion",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Jun Zhu","Peking University Cancer Hospital & Institute","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":24,"role":25},"Yuqin Song",[29],{"name":30,"role":31,"phone":32,"phoneExt":20,"email":33},"Sa Xiao, PHD","CONTACT","+86-15013238943","xiaosa@baili-pharm.com",[35,58,65],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50,53,56,57],{"name":23,"role":31,"phone":51,"phoneExt":20,"email":52},"010-88196115","zhujun3346@163.com",{"name":27,"role":31,"phone":54,"phoneExt":20,"email":55},"010-88196118","SongYQ_VIP@163.com",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"name":27,"role":25,"phone":20,"phoneExt":20,"email":20},{"facility":59,"status":37,"city":60,"state":61,"zip":20,"country":41,"countryCode":42,"cosmosGeoPoint":20,"geoPoint":20,"contacts":62},"Harbin First Hospital","Haerbin","Heilongjing",[63],{"name":64,"role":31,"phone":20,"phoneExt":20,"email":20},"Zhiguo Wang",{"facility":66,"status":37,"city":67,"state":68,"zip":20,"country":41,"countryCode":42,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Qingdao Central Hospital","Qingdao","Shandong",{"type":44,"coordinates":70},[71,72],120.38042,36.06488,{"lat":72,"lon":71},[75],{"name":76,"role":31,"phone":20,"phoneExt":20,"email":20},"Ling Wang",{"type":78,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[80,82],{"name":81,"class":6},"SystImmune Inc.",{"name":83,"class":6},"Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.","100487200","phase-1-a-study-of-gnc-038-injection-in-patients-with-relapsed-or-refractory-non-hodgkins-lymphoma-100487200",false,"NCT05623982","A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma","An Open, Multicenter, Phase Ib\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Tetra-specific Antibody GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)","Inclusion Criteria:\n\n1. The subject is capable of understanding the informed consent form, voluntarily participates, and signs the informed consent form;\n2. No gender restrictions;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Patients with histologically confirmed non-Hodgkin's lymphoma;\n6. Patients with relapsed or refractory non-Hodgkin's lymphoma (R\u002FR NHL);\n7. Presence of measurable lesions during the screening period (lymph node lesions with any long diameter ≥1.5 cm or extranodal lesions with any long diameter \\>1.0 cm);\n8. ECOG performance status score ≤2;\n9. Adverse reactions from prior anti-tumor treatment have recovered to ≤Grade 1 as per CTCAE 5.0 criteria;\n10. Organ function levels meet the requirements before the first dose;\n11. Female subjects of childbearing potential or male subjects with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 12 weeks after treatment discontinuation. Female subjects of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days before the first dose;\n12. The subject has the ability and willingness to comply with the study protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.\n\nExclusion Criteria:\n\n1. Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0; patients currently diagnosed with interstitial lung disease (ILD);\n2. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;\n3. Active tuberculosis;\n4. Patients with active autoimmune diseases;\n5. History of other malignancies within 5 years prior to the first dose;\n6. HBsAg-positive and\u002For HBcAb-positive with HBV-DNA levels ≥ the lower limit of detection; HCV antibody-positive with HCV-RNA levels ≥ the lower limit of detection; HIV antibody-positive;\n7. Poorly controlled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg);\n8. History of severe cardiovascular or cerebrovascular diseases;\n9. Patients with a history of hypersensitivity to recombinant humanized antibodies or any excipients of GNC-038;\n10. Pregnant or lactating women;\n11. Patients with central nervous system involvement;\n12. Major surgery within 28 days before the first dose of this study or planned major surgery during the study period;\n13. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n14. Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before initiating GNC-038 treatment;\n15. Current use of immunosuppressive therapy;\n16. Radiotherapy within 4 weeks before initiating GNC-038 treatment;\n17. Chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives prior to treatment;\n18. CAR-T therapy within 12 weeks before initiating GNC-038 treatment;\n19. Use of any other investigational drug in a clinical trial within 4 weeks or 5 half-lives before the first dose of this study;\n20. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.","ALL","18 Years","75 Years",{"count":95,"type":96},40,"ESTIMATED","INTERVENTIONAL",[99,100],"PHASE1","PHASE2","To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2D of GNC-038, or the MAD and DLT",[103],"Non-hodgkin's Lymphoma","2025-09-26",{"date":106,"type":107},"2025-09-29","ACTUAL",{"date":109,"type":107},"2022-09-26",{"date":111,"type":96},"2027-12",{"name":5,"class":6},3]