[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598092":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":47,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":73,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Essen Biotech","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Mesothelin and Claudin 18.2 CAR T cells, chemotherapy","EXPERIMENTAL","Patients will be administered fludarabine phosphate intravenously (IV) over a 30-minute period on days -4 to -2. Additionally, cyclophosphamide will be administered intravenously (IV) over 60 minutes on day -2. Subsequently, patients will receive Mesothelin and Claudin 18.2 CAR T cells intravenously (IV) over a duration of 10-20 minutes on day 0. Patients who exhibit positive responses to the initial dose of Mesothelin and Claudin 18.2 CAR T cells, do not experience unacceptable side effects, and have a sufficient quantity of cells available may be eligible to receive 2 or 3 additional doses of Mesothelin and Claudin 18.2 CAR T cells.",[13],"Biological: Mesothelin and Claudin 18.2 CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Mesothelin and Claudin 18.2 CAR-T cells","The intervention in this clinical trial involves a novel approach using Mesothelin and Claudin 18.2 Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies.\n\nTreatment Regimen:\n\nFludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy.\n\nCyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2.\n\nMesothelin and Claudin 18.2 Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, Mesothelin and Claudin 18.2 CAR T cells, over 10-20 minutes on day 0.\n\nAdditional Doses: Eligible patients responding well to the initial Mesothelin and Claudin 18.2 CAR-T cell infusion without unacceptable side effects and sufficient CAR-T cell availability may receive 2 or 3 additional doses.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Rhoda M Smith, Phd","CONTACT","+12077706670","clinical-trials@essen-biotech.com",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"District One Hospital","RECRUITING","Beijing","Beijing Municipality","086-373","China","CN",{"type":37,"coordinates":38},"Point",[39,40],116.39723,39.9075,{"lat":40,"lon":39},[43],{"name":44,"role":24,"phone":45,"phoneExt":20,"email":46},"SAMI XI, dr","+14012275001","SFM@districtonehospital.com",{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100598092","phase-1-mesothelin-and-claudin-182-dual-target-car-t-therapy-in-advanced-pancreatic-cancer-100598092",false,"NCT07066995","Mesothelin and Claudin 18.2 Dual-Target CAR-T Therapy in Advanced Pancreatic Cancer","Dual-Target Chimeric Antigen Receptor (CAR) T-Cell Therapy Directed Against Mesothelin and Claudin 18.2 in Patients With Advanced or Metastatic Pancreatic Cancer","BAH2573-102","Inclusion Criteria:\n\n* Expected survival time ≥3 months;\n* Histologically or cytologically confirmed pancreatic adenocarcinoma that is advanced (unresectable or metastatic). Patients should have received, or be intolerant of, standard first-line therapy (e.g., gemcitabine\u002Fnab-paclitaxel, FOLFIRINOX) for advanced disease. A short course of current first-line therapy is allowed for the purpose of bridging to manufacturing, but evidence of disease progression on or after at least one line is required prior to infusion (for the dose-expansion phase, patients must have progressed on ≥1 prior systemic regimen).\n* ECOG Performance Status: 0 or 1 (fully active or restricted in strenuous activity but ambulatory).\n* Liver and kidney function, cardiopulmonary function meet the following requirements:\n* Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;\n* Blood oxygen saturation \\>91% in non-oxygen state;\n* Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN.\n* No serious mental disorders;\n* Can understand this test and has signed the informed consent.\n\nExclusion Criteria:\n\n* Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) Antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) Antibody positive; Syphilis positive;\n* Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia;\n* Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;\n* Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration;\n* Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partners plan pregnancy within 2 years after cell transfusion;\n* Patients who received CAR-T therapy or other gene-modified cell therapy before screening;\n* Participated in other clinical studies 1 month before screening;\n* Evidence of central nervous system invasion during subject screening;\n* Mental patients with depression or suicidal thoughts;\n* Situations considered unsuitable for inclusion by other researchers.","ALL","21 Years","90 Years",{"count":61,"type":62},60,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE1","PHASE2","Autologous T-cells engineered to express CARs targeting Mesothelin and Claudin18.2, for Unresectable locally advanced or metastatic pancreatic adenocarcinoma (Pancreatic Ductal Adenocarcinoma, PDAC), administered as two separate sequential infusions following lymphodepleting chemotherapy",[69,70,71,72],"Pancreatic Cancer","Pancreatic Carcinoma","Pancreatic Cancer Non-resectable","Pancreatic Cancer Stage IV",[69,74,70,75,76],"claudin 18.2","CAR-T","Mesothelin","2025-07-04",{"date":79,"type":80},"2025-07-15","ACTUAL",{"date":82,"type":80},"2025-04-29",{"date":84,"type":62},"2028-12-28",{"name":5,"class":6},1]