[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550365":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":31,"responsibleParty":50,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":20,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Shanghai Cell Therapy Group Co.,Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CD19\u002FCD20\u002FBCMA CAR T therapy","EXPERIMENTAL","The safety and tolerability of BZE2204 will be assessed in a \"1+1+1+3\" and \"3+3\" dose escalation approach in different B-cell non-hodgkin lymphoma",[13],"Biological: CD19\u002FCD20\u002FBCMA CAR T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CD19\u002FCD20\u002FBCMA CAR T cells","Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CD19\u002FCD20\u002FBCMA CAR T cells.\n\nCyclophosphamide and fludarabine will be given from day-5 to day-3 before the infusion for lymphodepletion. On day0 subjects will receive one dose treatment with CD19\u002FCD20\u002FBCMA CAR T cells by intravenous (IV) injection",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Jinxing Lou","Shanghai Mengchao Cancer Hospital","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","021-67091399","loujx@shcell.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Mengchao Cancer Hospital","RECRUITING","Shanghai","Shanghai Municipality","201800","China","CN",{"type":41,"coordinates":42},"Point",[43,44],121.45806,31.22222,{"lat":44,"lon":43},[47,49],{"name":23,"role":28,"phone":48,"phoneExt":20,"email":30},"18911335396",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":51,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100550365","early-phase-1-a-dose-escalating-study-of-cd19cd22bcma-car-t-therapy-in-relapsed-or-refractory-b-cell-non-hodgkin-lymphomanhl-100550365",false,"NCT06446128","A Dose Escalating Study of CD19\u002FCD22\u002FBCMA CAR-T Therapy in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)","A Dose Escalating Study of CD19\u002FCD22\u002FBCMA Three Targets Autologous Chimeric Antigen Receptor T (CAR-T) Cell Therapy in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)","Key Inclusion Criteria:\n\n* Patients who are diagnosed with relapsed\u002Frefractory B cell non-Hodgkin lymphoma , especially\n\n  * Diffuse Large B Cell Lymphoma, not other specified (DLBCL,NOS),\n  * Primary Mediastinal Large B Cell Lymphoma (PMBCL)\n  * Transformation Follicular Lymphoma (TFL)\n  * High grade B-cell lymphoma(HGBCL)\n  * High grade B-cell lymphoma (HGBCL) with MYC(myelocytomatosis oncogene) and BCL2(B-cell lymphoma2) \u002FBCL6 (B-cell lymphoma6) rearrangement\n* Refractory diseases are defined as one of the following\n\n  * No response to last line of therapy: i. Progressive disease (PD) as best response to most recent therapy regimen; ii. Stable disease (SD) as best response to most recent therapy regimen\n  * Not candidate for autologous stem cell transplant (ASCT) or refractory post-ASCT: i. Disease progression (PD) or relapsed ≤12 months of ASCT (must have biopsy proven recurrence in relapsed individuals) ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy\n* Individuals must have received adequate prior therapy including at a minimum:\n\n  * anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative and\n  * an anthracycline containing chemotherapy regimen\n* Immunohistochemical staining shows at least two of B cell surface receptor antigen CD19,CD20, BCMA are positive(including weak, medium and strong positive)\n* At least one measurable lesion during the screening based on the recommendation for initial evaluation, staging and response assessment of Hodgkin and non-Hodgkin lymphoma.\n* Life expectancy ≥ 12 weeks\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n* Adequate renal, hepatic, pulmonary and cardiac function defined as:\n\n  * Renal function: Serum creatinine ≤ 1.5 upper limit of normal(ULN), or eGFR ≥ 60 mL\u002Fmin\u002F1.73m2 \\[eGFR(estimated glomerular filtration rate)=186×age\\^-0.203×SCr\\^-1.154（mg\u002Fdl）,female×0.742\\]\n  * Hepatic function: i: Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤ 5 ULN and ii: total bilirubin ≤ 2 ULN, except in individuals with Gilbert syndrome (in Gilbert's syndrome patients, those with total bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN can be enrolled).iii: International normalized ratio (INR) or prothrombin time (PT) ≤1.5 ULN Pulmonary: Have the minimum level of pulmonary reserve, defined as ≤ CTCAE (Common Terminology Criteria for Adverse Events) grade 1 dyspnea and the SaO2(oxygen saturation)≥ 91% on room air\n  * Cardiac: left ventricular ejection fraction (LVEF) ≥50% determined by echocardiogram(ECG) or multigated acquisition scan (MUGA)\n* Adequate bone marrow function, define as:\n\n  * absolute neutrophil count (ANC) ≥1 ×10\\^9\u002FL\n  * absolute lymphocyte count (ALC)≥ 0.5 ×10\\^9\u002FL\n  * Platelets ≥50 ×109\u002FL；\n  * Hemoglobulin ≥80 g\u002FL; patients with bone marrow involvement can be enrolled if globulin\\>60 g\u002FL\n* Female of child-bearing age and male participants must agree to use effective contraceptive methods until no CAR-T cells can be detected by PCR(polymerase chain reaction) test.\n\nKey Exclusion Criteria:\n\n* Individuals who have antiCD45 or antiCD3 therapy\n* Individuals with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of primary or secondary CNS (central nervous system) lymphoma, cerebrospinal fluid malignant cells or brain metastases\n* Presence or history of CNS disorder such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n* History of allogeneic stem cell transplantation\n* Any of the following situations:\n\n  • HBsAg\u002F HBeAg positive; HBeAb\u002FHBcAb positive and HBV(hepatitis B virus) DNA copies above the lower test limit;\n* HCV(hepatitis C virus) RNA positive\n* HIV(human immunodeficiency virus) positive or treponema pallidum positive\n* Presence of active or life-threatening fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.\n* Individuals presence of unstable angina or myocardial infarction within 6 months of screening, or other severe\u002Funcontrolled diseases during the screening (eg. Unstable or uncompensated respiratory, cardiac, hepatic or renal disease)\n* Presence of uncontrolled arrhythmia with treatment\n* Pregnancy or breastfeeding women\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":62,"type":63},20,"ESTIMATED","INTERVENTIONAL",[66],"EARLY_PHASE1","This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19\u002FCD22\u002FBCMA in patients with relapsed or refractory B cell non-Hodgkin lymphoma.",[69],"Non-Hodgkin Lymphoma, B-cell",[71,72,73,74,75],"B cell non-hodgkin lymphoma","CAR-T","CD19","CD22","BCMA","2025-08-19",{"date":78,"type":79},"2025-08-21","ACTUAL",{"date":81,"type":79},"2024-05-07",{"date":83,"type":63},"2026-12-31",{"name":5,"class":6},1]