[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"esophageal-adenocarcinomas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:esophageal-adenocarcinomas":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"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":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31,32,33],"Mesothelin Positive","Mesothelin-Expressing Tumors","Esophageal Adenocarcinoma","Esophageal Adenocarcinomas","Esophagogastric Adenocarcinoma","Peritoneal Carcinomatosis","Breast Neoplasms","Diabetes Mellitus",[35,36,37,38,39,40,41,42],"mesothelin positive","mesothelin-expressing tumors","esophageal adenocarcinoma","esophageal adenocarcinomas","esophagastric adenocarcinoma","peritoneal carcinomatosis","CAR T-Cell Therapy","24-214","RECRUITING","2026-02-09",{"date":46,"type":47},"2026-02-11","ACTUAL",{"date":49,"type":47},"2024-09-30",{"date":51,"type":20},"2028-09-30",{"name":53,"class":54},"Memorial Sloan Kettering Cancer Center","OTHER",7]