[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rr-b-nhl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rr-b-nhl":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100619524","clinical-study-on-the-safety-and-efficacy-of-cd20cd19-cell-injection-in-the-treatment-of-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-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":19,"type":20},28,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.",[26,27],"R\u002FR B-NHL","Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (R\u002FR B-NHL)",[29],"relapsed or refractory B-cell non-Hodgkin lymphoma (R\u002FR B-NHL)","NOT_YET_RECRUITING","2026-01-07",{"date":33,"type":34},"2026-01-16","ACTUAL",{"date":36,"type":20},"2025-12-31",{"date":38,"type":20},"2030-12-31",{"name":40,"class":41},"Donghua Zhang","OTHER"]