[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563994":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":118,"collaborators":20,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":20,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":20,"enrollmentInfo":129,"targetDuration":20,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":145,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"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",[35,51,62,73,85,96,107],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","RECRUITING","Basking Ridge","New Jersey","07920","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-74.54932,40.70621,{"lat":47,"lon":46},[50],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":52,"status":37,"city":53,"state":39,"zip":54,"country":41,"countryCode":42,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Memorial Sloan Kettering Monmouth (Limited protocol activities)","Middletown","07748",{"type":44,"coordinates":56},[57,58],-74.11709,40.39428,{"lat":58,"lon":57},[61],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":63,"status":37,"city":64,"state":39,"zip":65,"country":41,"countryCode":42,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",{"type":44,"coordinates":67},[68,69],-74.02292,41.04676,{"lat":69,"lon":68},[72],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":74,"status":37,"city":75,"state":76,"zip":77,"country":41,"countryCode":42,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)","Commack","New York","11725",{"type":44,"coordinates":79},[80,81],-73.29289,40.84288,{"lat":81,"lon":80},[84],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":86,"status":37,"city":87,"state":76,"zip":88,"country":41,"countryCode":42,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",{"type":44,"coordinates":90},[91,92],-73.71263,40.96899,{"lat":92,"lon":91},[95],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":97,"status":37,"city":76,"state":76,"zip":98,"country":41,"countryCode":42,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",{"type":44,"coordinates":100},[101,102],-74.00597,40.71427,{"lat":102,"lon":101},[105,106],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"facility":108,"status":37,"city":109,"state":76,"zip":110,"country":41,"countryCode":42,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","Uniondale","11553",{"type":44,"coordinates":112},[113,114],-73.59291,40.70038,{"lat":114,"lon":113},[117],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"type":119,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100563994","phase-1-a-study-of-mesothelin-targeted-car-t-cell-therapy-in-people-with-esophagogastric-cancer-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":130,"type":131},18,"ESTIMATED","INTERVENTIONAL",[134],"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.",[137,138,139,140,141,142,143,144],"Mesothelin Positive","Mesothelin-Expressing Tumors","Esophageal Adenocarcinoma","Esophageal Adenocarcinomas","Esophagogastric Adenocarcinoma","Peritoneal Carcinomatosis","Breast Neoplasms","Diabetes Mellitus",[146,147,148,149,150,151,152,153],"mesothelin positive","mesothelin-expressing tumors","esophageal adenocarcinoma","esophageal adenocarcinomas","esophagastric adenocarcinoma","peritoneal carcinomatosis","CAR T-Cell Therapy","24-214","2026-02-09",{"date":156,"type":157},"2026-02-11","ACTUAL",{"date":159,"type":157},"2024-09-30",{"date":161,"type":131},"2028-09-30",{"name":5,"class":6},7]