[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619524":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":12,"studyPopulation":12,"armGroups":19,"interventions":25,"overallOfficials":12,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":12,"id":55,"slug":12,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":12,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":12,"studyType":66,"phases":67,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":74,"whyStopped":12,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Tongji Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":12},[9],{"measure":10,"description":11,"timeFrame":11},"Overall survival","Time frame:1, 3,6,12,18, 24 months after treatment",null,{"allocation":14,"interventionModel":15,"interventionModelDescription":12,"primaryPurpose":16,"observationalModel":12,"timePerspective":12,"maskingInfo":17},"NA","SINGLE_GROUP","TREATMENT",{"masking":18,"maskingDescription":12,"whoMasked":12},"NONE",[20],{"label":21,"type":22,"description":12,"interventionNames":23},"Experimental:Experimental group","EXPERIMENTAL",[24],"Drug: AcNK-Sup003 cell injection",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":12},"DRUG","AcNK-Sup003 cell injection","AcNK-Sup003 cell injection in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (R\u002FR B-NHL)",[21],[32],{"name":33,"role":34,"phone":35,"phoneExt":12,"email":36},"Andie Fu","CONTACT","15926614832","andie_fu@163.com",[38],{"facility":39,"status":12,"city":40,"state":12,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology","Wuhan","China","CN",{"type":44,"coordinates":45},"Point",[46,47],114.26667,30.58333,{"lat":47,"lon":46},[50],{"name":33,"role":34,"phone":35,"phoneExt":12,"email":36},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Donghua Zhang","professor","100619524",false,"NCT07345741","Clinical Study on the Safety and Efficacy of CD20\u002FCD19 Cell Injection in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\nWritten informed consent: Signed written informed consent and ability to comply with protocol-specified visits and procedures.\n\nAge and life expectancy: Age ≥ 18 years with an expected survival of more than 3 months.\n\nPathological diagnosis: Histopathologically confirmed CD20+ relapsed or refractory B-cell non-Hodgkin lymphoma (according to WHO 2016 lymphoma classification), including but not limited to:\n\nDiffuse large B-cell lymphoma (DLBCL) High-grade B-cell lymphoma (HGBCL) Follicular lymphoma grade 3b (3b FL)\n\nRelapsed or refractory disease: Defined by meeting one or more of the following:\n\nRelapse, non-response, or progression after hematopoietic stem cell transplantation Stable disease for ≤ 6 months after at least two cycles of second-line therapy (DLBCL\u002FHGBCL\u002F3b FL subtypes must have received CD20-targeted agents and anthracyclines; other subtypes evaluated by investigator for treatment adequacy) Disease progression or relapse after at least second-line therapy (DLBCL\u002FHGBCL\u002F3b FL subtypes must have received CD20-targeted agents and anthracyclines; other subtypes evaluated by investigator for treatment adequacy) ECOG performance status: 0-2.\n\nContraception requirements:\n\nFertile males and females of childbearing potential must agree to use effective contraception from signing informed consent until 6 months after last study drug administration Negative serum pregnancy test required for females of childbearing potential at screening\n\nMeasurable disease: At least one measurable lesion according to Lugano 2014 criteria:\n\nLymph node lesions \\> 15mm in longest diameter on CT Extranodal lesions \\> 10mm in longest diameter FDG-PET positive (SUV ≥ 4 or 5) Radiated lesions only considered measurable if progression documented after completion of radiotherapy\n\nHematological parameters (no blood transfusion or hematopoietic growth factor within 7 days prior to testing):\n\nHemoglobin (Hb) ≥ 80 g\u002FL Absolute neutrophil count (ANC) ≥ 1×10⁹\u002FL Platelet count (PLT) ≥ 50×10⁹\u002FL\n\nCoagulation function:\n\nInternational Normalized Ratio (INR) ≤ 1.5×ULN Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN (INR 2.0-3.0 acceptable for subjects on prophylactic anticoagulation)\n\nOrgan function requirements:\n\nRenal: Serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula) Hepatic: Total bilirubin ≤ 1.5×ULN (≤ 3×ULN for liver infiltration or Gilbert's syndrome); ALT and AST ≤ 3×ULN (≤ 5×ULN for liver infiltration) Pulmonary: Oxygen saturation ≥ 92% on room air Subjects failing to meet any of the above criteria will not be eligible for enrollment.\n\nExclusion Criteria:\n\nPrimary CNS involvement: Primary central nervous system lymphoma or active CNS involvement\u002Fsymptoms.\n\nAutoimmune conditions: Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, autoimmune thrombocytopenia) or uncontrolled pleural effusions.\n\nCardiovascular history:\n\nSevere cardiac rhythm\u002Fconduction abnormalities requiring intervention QTcF prolongation (\\> 450 ms males, \\> 470 ms females) Acute coronary syndrome, heart failure, aortic dissection, stroke, or other ≥ grade 3 cardiovascular events within 6 months NYHA class ≥ II heart failure or LVEF \\\u003C 50% Uncontrolled hypertension (systolic ≥ 160 mmHg and\u002For diastolic ≥ 100 mmHg despite medication)\n\nPrior cell therapies\u002Ftransplants:\n\nAutologous stem cell transplant or cell therapy within 3 months Allogeneic stem cell transplant or cell therapy within 6 months History of solid organ transplantation Prior anticancer therapy: Anticancer treatment or participation in other interventional clinical studies within 4 weeks or 5 half-lives (whichever is shorter) before lymphodepletion.\n\nRecent procedures\u002Fvaccinations: Live attenuated vaccine or major surgery within 4 weeks before lymphodepletion, or planned during study.\n\nSystemic steroids: Requirement for prolonged (≥ 3 days) systemic steroid therapy (≥ 10 mg\u002Fday prednisone equivalent) during study (inhaled or topical steroids excluded).\n\nOther malignancies\u002Fconditions: History of other malignancies (except cured in-situ cervical cancer, non-invasive skin cancers, or locally treated prostate\u002Fbreast carcinoma with ≥ 2 years remission); severe diabetes or other serious comorbidities.\n\nActive infections: Active fungal, bacterial, viral, or mycobacterial infections requiring systemic treatment within 14 days before lymphodepletion.\n\nInfectious diseases:\n\nHBsAg positive or HBcAb positive with detectable HBV DNA HCV antibody positive with detectable HCV RNA HIV antibody positive Active syphilis Hypersensitivity: Life-threatening hypersensitivity or intolerance to study medications or severe allergic diathesis.\n\nPregnancy\u002Flactation: Pregnant or breastfeeding females. Other factors: Any condition deemed by investigator to affect compliance or make subject unsuitable for study participation.","ALL","18 Years","78 Years",{"count":64,"type":65},28,"ESTIMATED","INTERVENTIONAL",[14],"Evaluate the safety and tolerability of AcNK-Sup003 cell injection in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (R\u002FR B-NHL). To preliminarily determine the Maximum Tolerated Dose (MTD) or recommended clinical dose of AcNK-Sup003 cell injection.",[70,71],"R\u002FR B-NHL","Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (R\u002FR B-NHL)",[73],"relapsed or refractory B-cell non-Hodgkin lymphoma (R\u002FR B-NHL)","NOT_YET_RECRUITING","2026-01-07",{"date":77,"type":78},"2026-01-16","ACTUAL",{"date":80,"type":65},"2025-12-31",{"date":82,"type":65},"2030-12-31",{"name":53,"class":6},1]