[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615568":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":38,"collaborators":11,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":11,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":11,"enrollmentInfo":49,"targetDuration":11,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":11,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"QLS2313","EXPERIMENTAL",null,[13],"Drug: QLS2313",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","CD79b\u002FCD3\u002FCD20;first in human; subcutaneous injection",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Weili Zhao, PhD","CONTACT","15214370575","zwl_trial@163.com",[26],{"facility":27,"status":11,"city":28,"state":29,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":11},"Shanghai Jiaotong University School of Medicine Ruijin Hospital","Shanghai","Shanghai Municipality","China","CN",{"type":33,"coordinates":34},"Point",[35,36],121.45806,31.22222,{"lat":36,"lon":35},{"type":39,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100615568","phase-1-a-phase-i-trial-of-qls2313-injection-in-relapsedrefractory-hematological-malignancies-100615568",false,"NCT07294300","A Phase I Trial of QLS2313 Injection in Relapsed\u002FRefractory Hematological Malignancies","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS2313 for Injection in Patients With Relapsed\u002FRefractory Hematological Malignancies","Inclusion Criteria:\n\n1. Males or females aged ≥ 18 years；\n2. Patients with relapsed\u002Frefractory hematological malignancies, specifically patients with B-cell NHL or CLL\u002Fsmall lymphocytic lymphoma (SLL) as defined by the 2022 World Health Organization (WHO) classification, who are relapsed\u002Frefractory and have no standard of care available as judged by the investigator;\n3. Having a measurable disease defined by appropriate disease response criteria;\n4. Subjects with sufficient organ function prior to the first dose of the investigational drug\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1\n\nExclusion Criteria:\n\n1. Previous treatment with a CD79b\u002FCD3\u002FCD20 trispecific antibody；\n2. Known central nervous system (CNS) involvement；\n3. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\u002Fbone marrow transplantation；\n4. Treatment with autologous stem cell transplantation within 3 months;\n5. Prior genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T cells \\[CAR-T\\] and natural killer cells \\[CAR-NK\\]) within 3 months\n6. Presence of viral, bacterial or uncontrolled fungal infection requiring intravenous drug infusion within 1 week prior to the first dose\n7. Presence of chronic or acute active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV-5 test at screening indicating active infection (positive HBsAg and\u002For positive HBcAb) with HBV-DNA \\> ULN, or positive HCVAb and positive HCV-RNA, allowed for antiviral therapy.","ALL","18 Years",{"count":50,"type":51},124,"ESTIMATED","INTERVENTIONAL",[54],"PHASE1","This study is an open-label, dose-escalation and efficacy-expansion Phase I clinical trial to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary antitumor activity of QLS2313 as a monotherapy in patients with relapsed\u002Frefractory hematological malignancies.",[57],"Relapsed\u002FRefractory Hematological Malignancies","NOT_YET_RECRUITING","2025-12-08",{"date":61,"type":62},"2025-12-19","ACTUAL",{"date":64,"type":51},"2026-01",{"date":66,"type":51},"2028-02",{"name":5,"class":6},1]