[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563994":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":117,"collaborators":20,"id":119,"slug":20,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":20,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":20,"enrollmentInfo":127,"targetDuration":20,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":143,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with Mesothelin-Positive Esophagogastric Adenocarcinoma with Peritoneal Carcinomatosis","EXPERIMENTAL","Participants will be diagnoses with Mesothelin-Positive Esophagogastric Adenocarcinoma with Peritoneal Carcinomatosis",[13],"Biological: M28z1XXPD1DNR CAR",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","M28z1XXPD1DNR CAR","Participants with esophagastric adenocarcinoma will be treated with an intraperitoneal infusion of different doses of autologous T cells that have been genetically modified ex vivo to express the M28z1XXPD1DNR CAR. The CAR T cells will be manufactured in MSK's Center for Cell Engineering.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Geoffrey Ku, MD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","646-888-4588","kug@mskcc.org",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Parastoo Dahi, MD","646-608-3733","dahip@mskcc.org",[35,50,61,72,84,95,106],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","RECRUITING","Basking Ridge","New Jersey","07920","United States",{"type":43,"coordinates":44},"Point",[45,46],-74.54932,40.70621,{"lat":46,"lon":45},[49],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":51,"status":37,"city":52,"state":39,"zip":53,"country":41,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Memorial Sloan Kettering Monmouth (Limited protocol activities)","Middletown","07748",{"type":43,"coordinates":55},[56,57],-74.11709,40.39428,{"lat":57,"lon":56},[60],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":62,"status":37,"city":63,"state":39,"zip":64,"country":41,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",{"type":43,"coordinates":66},[67,68],-74.02292,41.04676,{"lat":68,"lon":67},[71],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":73,"status":37,"city":74,"state":75,"zip":76,"country":41,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)","Commack","New York","11725",{"type":43,"coordinates":78},[79,80],-73.29289,40.84288,{"lat":80,"lon":79},[83],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":85,"status":37,"city":86,"state":75,"zip":87,"country":41,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",{"type":43,"coordinates":89},[90,91],-73.71263,40.96899,{"lat":91,"lon":90},[94],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":96,"status":37,"city":75,"state":75,"zip":97,"country":41,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",{"type":43,"coordinates":99},[100,101],-74.00597,40.71427,{"lat":101,"lon":100},[104,105],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"facility":107,"status":37,"city":108,"state":75,"zip":109,"country":41,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","Uniondale","11553",{"type":43,"coordinates":111},[112,113],-73.59291,40.70038,{"lat":113,"lon":112},[116],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"type":118,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100563994",false,"NCT06623396","A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer","A Phase I Trial of Intraperitoneal Mesothelin-Targeted CAR T-Cell Therapy in Patients With Mesothelin-Positive Esophagogastric Adenocarcinoma With Peritoneal Carcinomatosis","Inclusion Criteria:\n\n* Aged ≥18 years\n* Diagnosis of pathologically confirmed EG adenocarcinoma\n* Diagnosis of metastatic or recurrent disease\n* ECOG performance status of 0-1\n* Life expectancy of ≥4 months\n\nInclusion Criteria for Leukapheresis:\n\n* Written informed consent for the study (from participant)\n* Life expectancy of ≥4 months\n* ECOG performance status of 0-1\n* Histologic diagnosis that \\& \\>25% of the tumor expresses MSLN by IHC analysis. Archival tissue obtained up to 2 years before study enrollment is acceptable. IHC testing of a cell block from cytology (e.g., ascitic fluid) is acceptable if approved by the study pathologist. If adequate archival tissue is not available at screening, a fresh tumor biopsy should be obtained\n* Stage IV disease with gross peritoneal carcinomatosis on imaging and\u002For microscopic peritoneal involvement by cytology or noted during diagnostic laparoscopy\n* Disease progression or treatment intolerance after receiving at least 1 treatment regimen in the metastatic setting; patients with disease recurrence within 6 months of completing curative systemic therapy (chemotherapy, chemoradiation or adjuvant immunotherapy) are also eligible\n* Patients with Her2 positive disease must have received ≥1 line of anti-Her2 based therapy\n* At least 1 measurable or evaluable lesion per RECIST 1.1. Screening imaging must be obtained within 6 weeks of signing the informed consent form\n* Completion of systemic therapy at least 7 days before leukapheresis\n\n  o Immune checkpoint inhibitor therapy must be completed at least 14 days before leukapheresis\n* Lab requirements (hematology):\n\n  * Absolute neutrophil count ≥1.0 K\u002FmcL\n  * Hemoglobin ≥9 gm\u002FdL\n  * Platelet count ≥75 K\u002FmcL\n  * Blood product transfusion or growth factor support cannot occur within 7 days of testing\n* Lab requirements (serum chemistry):\n\n  * Bilirubin ≤1.5× upper limit of normal (ULN)\n  * Serum alanine aminotransferase and serum aspartate aminotransferase (ALT\u002FAST) level ≤3× ULN\n  * Calculated clearance of ≥50 mL\u002Fmin by Cockcroft-Gault equation\n* Negative screen for infectious disease markers, including hepatitis B core antibody, hepatitis B surface antigen, hepatitis C antibody, HIV 1-2 antibody, HTLV antibody and syphilis antibody\n\n  o Note: Patients with a history of hepatitis B virus infection are eligible if the hepatitis B viral load is undetectable. Patients with a history of hepatitis C virus infection who were treated for hepatitis C and cured are eligible if the hepatitis C viral load is undetectable\n* Serum pregnancy test with negative result at screening and preconditioning and must be willing to use effective and reliable contraception for at least 12 months after T cell infusion (for female participants of childbearing age)\n* Resolution of all acute toxic effects of any previous therapeutic or palliative chemotherapy, radiotherapy, or surgical procedures to grade ≤1 (CTCAE v5.0), except for neuropathy and alopecia\n\nInclusion Criteria for lymphodepleting chemotherapy\u002FCAR T cell infusion\n\n* Life expectancy of ≥4 months\n* ECOG performance status of 0-1\n* At least 1 measurable or evaluable lesion per RECIST 1.1. Screening imaging must be obtained within 4 weeks before the date of lymphodepletion\n* Completion of systemic therapy at least 14 days before lymphodepleting chemotherapy\n\n  o Immune checkpoint inhibitor therapy must be completed at least 28 days before lymphodepleting chemotherapy\n* Lab requirements (hematology):\n\n  * Absolute neutrophil count ≥1.5 K\u002FmcL\n  * Hemoglobin ≥8 gm\u002FdL\n  * Platelet count ≥75 K\u002FmcL\n* Lab requirements (serum chemistry):\n\n  * Bilirubin ≤1.5× upper limit of normal (ULN)\n  * Serum alanine aminotransferase and serum aspartate aminotransferase (ALT\u002FAST) level ≤3× ULN\n  * Calculated clearance of ≥50 mL\u002Fmin by Cockcroft-Gault equation\n* Serum pregnancy test with negative result within 7 days of planned lymphodepletion date and must be willing to use effective and reliable contraception for at least 12 months after T cell infusion (for female participants of childbearing age)\n* Resolution of all acute toxic effects of any previous therapeutic or palliative chemotherapy, radiotherapy, or surgical procedures to grade ≤1 (CTCAE v5.0), except for neuropathy and alopecia\n\nParticipant Exclusion Criteria\n\nExclusion Criteria for Leukapheresis or Lymphodepleting chemotherapy\u002FCAR T cell infusion: Participants are excluded from enrollment if any of the following criteria apply:\n\n* Pregnant or lactating\n* HIV, active hepatitis C virus, or active hepatitis B virus infection, as determined by quantitative PCR (patients who have undergone negative testing prior to leukapheresis do not require repeat testing)\n* Receiving therapy for concurrent active malignancy\n\n  * Note: Patients receiving treatment for in situ skin malignancies are not excluded.\n  * Patients with any malignancy diagnosed \\>3 years before that is thought to be curatively treated and\u002For has a low risk of recurrence are eligible. Patients may continue to receive adjuvant therapy at the time of study enrollment (e.g., adjuvant hormonal therapy for curatively treated breast cancer).\n* Known hematologic malignancy requiring treatment in the preceding 5 years or a known history of lymphoid malignancy\n* Previous receipt of CAR T cell therapy or any other cellular therapy\n* Previous mesothelin-directed therapy Any major abdominal surgery (laparotomy with resection of gastrointestinal tract or organ resection) that is completed \\<28 days before study enrollment. Patients who have undergone diagnostic laparoscopy can be included in the study without regard to timing\n* Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible if all of the following criteria are met:\n\n  * Radiographic demonstration of improvement upon completion of CNS-directed therapy and no evidence of interim progression between completion of CNS-directed therapy and the screening radiographic study\n  * Completion of radiotherapy ≥4 weeks before the screening radiographic study\n* Active autoimmune disease that has required systemic treatment within 1 year before leukapheresis (with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)\n\n  o Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Receiving daily systemic corticosteroids ≥10 mg of prednisone daily or equivalent or receiving immunosuppressive or immunomodulatory treatment\n* Any of the following cardiac conditions:\n\n  * New York Heart Association stage III or IV congestive heart failure\n  * Myocardial infarction ≤6 months before enrollment\n  * History of myocarditis\n  * Serious uncontrolled cardiac arrhythmia, unstable angina, or uncontrolled infection\n  * Left ventricular ejection fraction ≤40%\n* Active interstitial lung disease\u002Fpneumonitis or a history of interstitial lung disease\u002Fpneumonitis requiring treatment with systemic steroids\n* Baseline pulse oximetry \\<90% on room air at the screening time point\n* Known active infection requiring antibiotic treatment 7 days before leukapheresis\n\n  o Note: Treatment can be delayed at the discretion of the treating physician to allow the patient to recover from the infection.\n* Any other medical condition, e.g. fever \\>38.0 degrees C, that, in the opinion of the PI, may interfere with the subject's participation in or compliance with the study\n* Receipt of live, attenuated vaccine within 8 weeks before the planned lymphodepleting chemotherapy date\n* Deemed to be noncompliant by the study team for administration of a high-risk treatment agent and for close follow-up after treatment as required by the protocol","ALL","18 Years",{"count":128,"type":129},18,"ESTIMATED","INTERVENTIONAL",[132],"PHASE1","Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory at Memorial Sloan Kettering to be changed (modified) to become MSLN-targeted CAR T cells, the CAR T-cell therapy that participants will receive during the study. Participant study therapy will take about 3-4 weeks.",[135,136,137,138,139,140,141,142],"Mesothelin Positive","Mesothelin-Expressing Tumors","Esophageal Adenocarcinoma","Esophageal Adenocarcinomas","Esophagogastric Adenocarcinoma","Peritoneal Carcinomatosis","Breast Neoplasms","Diabetes Mellitus",[144,145,146,147,148,149,150,151],"mesothelin positive","mesothelin-expressing tumors","esophageal adenocarcinoma","esophageal adenocarcinomas","esophagastric adenocarcinoma","peritoneal carcinomatosis","CAR T-Cell Therapy","24-214","2026-02-09",{"date":154,"type":155},"2026-02-11","ACTUAL",{"date":157,"type":155},"2024-09-30",{"date":159,"type":129},"2028-09-30",{"name":5,"class":6},7]