[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496217":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":73,"collaborators":75,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":30,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":30,"enrollmentInfo":92,"targetDuration":30,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":30,"overallStatus":35,"whyStopped":30,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Bioray Laboratories","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","5- 10.0×10\\^6\u002FkgBW",[13],"Drug: CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection",[9],[20],"BRL-201",[22],{"name":23,"affiliation":5,"role":24},"Wei Li","STUDY_CHAIR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Wei Li, PhD","CONTACT","18621670308",null,"wli@brlmed.com",[33,49,61],{"facility":34,"status":35,"city":36,"state":37,"zip":30,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Wuhan Union Hospital","RECRUITING","Wuhan","Hubei","China","CN",{"type":41,"coordinates":42},"Point",[43,44],114.26667,30.58333,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":30,"phoneExt":30,"email":30},"Heng Mei, PhD",{"facility":50,"status":35,"city":51,"state":52,"zip":30,"country":38,"countryCode":39,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Tianjin Institute of Hematology","Tianjin","Tianjin Municipality",{"type":41,"coordinates":54},[55,56],117.17667,39.14222,{"lat":56,"lon":55},[59],{"name":60,"role":28,"phone":30,"phoneExt":30,"email":30},"Rugui qiu, PhD",{"facility":62,"status":35,"city":63,"state":64,"zip":30,"country":38,"countryCode":39,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"The First Affiliated Hospital of Zhejiang University","Hangzhou","Zhejiang",{"type":41,"coordinates":66},[67,68],120.16142,30.29365,{"lat":68,"lon":67},[71],{"name":72,"role":28,"phone":30,"phoneExt":30,"email":30},"He Huang, PhD",{"type":74,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[76,79,81],{"name":77,"class":78},"Chinese Academy of Medical Sciences","OTHER",{"name":80,"class":78},"Zhejiang University",{"name":82,"class":78},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","100496217","phase-1-the-safety-and-efficacy-of-brl-201-in-the-treatment-of-rr-b-lymphocyte-non-hodgkin-lymphoma-100496217",false,"NCT05741359","The Safety and Efficacy of BRL-201 in the Treatment of r\u002Fr B Lymphocyte Non-Hodgkin Lymphoma","A Phase I\u002FII Clinical Study of the Safety and Efficacy of CD19-targeted Non-viral PD1 Site-specific Integrated CAR-T Cell Injection (BRL-201) in the Treatment of Relapsed or Refractory B Lymphocyte Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Willing to participate in this clinical study and sign an informed consent form;\n2. Age ≥ 18 years old;\n3. Estimated survival time ≥ 3 months;\n4. Presence of at least one measurable lesion as assessed according to Lugano Classification 2014 for response assessment in lymphomas (i.e., the cross-sectional images obtained by CT show that the long diameter of lymph node lesions is \\> 15 mm or the long diameter of extranodal lesions is \\> 10 mm, and FDG-PET scan results are positive). Lesions, for which radiotherapy was provided, can be regarded as measurable lesions only if there is an unequivocal progression after radiotherapy;\n5. Histopathologically confirmed aggressive B-NHL; positive expression of CD19 in tumors detected by immunohistochemistry or flow cytometry; pathological types of B-NHL (according to WHO Lymphoma Classification 2016);\n6. Relapsed or refractory diseases;\n7. Subjects who must receive adequate prior therapy;\n8. Absence of invasion of central nervous system (CNS) lymphoma by cranial magnetic resonance imaging (MRI);\n9. Hematological parameters meeting the requirements;\n10. Blood biochemistry meeting the requirements;\n11. LVEF ≥ 55%;\n12. No severe pulmonary disorders;\n13. Toxic reactions induced by prior anti-lymphoma therapy must be stable and resolved to grade ≤ 1;\n14. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n15. Patients with physical conditions for apheresis of peripheral blood; 16 . Willing to abide by the rules formulated in the study protocol.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Subjects who previously received allogeneic cell therapies, including allogeneic stem cell transplant;\n3. Subjects who previously received anti-CD19 targeted therapy, except those who receive BRL-201 and are eligible to receive reinfusion in this study;\n4. Prior treatment with any CAR-T cell product or other genetically modified T cell therapies;\n5. History of Richter's transformation of chronic lymphocytic leukemia (CLL);\n6. Presence of uncontrollable fungal, bacterial, viral, or other infections requiring systemic therapy. Patients can be enrolled if the simple urinary tract infection or pharyngitis responds to treatment;\n7. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;\n8. Severe mental disorders; history of CNS disorders (e.g., epileptic seizure, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or any CNS-involved autoimmune disorders);\n9. Active autoimmune disorders requiring immunotherapy, including but not limited to end organ damages caused by autoimmune disorders (e.g., Crohn's disease, rheumatoid arthritis, and systemic lupus erythematosus) in the past 2 years, or requiring systemic application of immunosuppressive drugs or other drugs for systemic control of diseases;\n10. Primary immunodeficiency;\n11. History of other malignancies;\n12. Patients with severe cardiovascular disorders, including but not limited to those with lymphoma infiltration in the cardiac atrium or ventricles and those with a history of myocardial infarction, cardioangioplasty or stent implantation, unstable angina, or other clinically significant heart diseases within 12 months before enrollment;\n13. History of deep venous thrombosis or pulmonary embolism within 6 months before enrollment;\n14. Patients who are receiving oral anticoagulant therapy; prothrombin time (PT), activated partial thromboplastin time (APTT), or international normalized ratio (INR) \\> 1.5 × ULN without anticoagulant therapy;\n15. Presence of any indwelling tube or catheter (e.g., tube or catheter for percutaneous nephrostomy, indwelling catheter, or catheter in pleural cavity\u002Fperitoneal cavity\u002Fpericardium). Dedicated central venous access catheters (e.g., Port-a-Cath or Hickman catheter) are permitted;\n16. Lymphoma cells detected in cerebrospinal fluid, presence of brain metastases, history of CNS lymphoma, or history of lymphoma cells detected in cerebrospinal fluid or brain metastases;\n17. Conditions (e.g., intestinal obstruction or vascular compression) requiring emergency treatment due to tumor masses;\n18. History of severe immediate hypersensitivity to any drug to be used in this study;\n19. Vaccination of live vaccines, excluding corona virus disease 2019 (COVID-19) vaccines, within ≤ 6 weeks before the start of the pretreatment regimen;\n20. Any circumstances that possibly increase the risk of subjects or interfere with the study results as judged by the investigator.","ALL","18 Years",{"count":93,"type":94},18,"ESTIMATED","INTERVENTIONAL",[97],"PHASE1","This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects.",[100],"Non-hodgkin Lymphoma,B Cell","2025-11-20",{"date":103,"type":104},"2025-11-25","ACTUAL",{"date":106,"type":104},"2023-04-25",{"date":108,"type":94},"2027-01-15",{"name":5,"class":6},3]