[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520064":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":43,"locations":49,"responsibleParty":247,"collaborators":249,"id":252,"slug":37,"hasResults":253,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":253,"sex":259,"minAge":260,"maxAge":37,"enrollmentInfo":261,"targetDuration":37,"studyType":264,"phases":265,"briefSummary":268,"conditions":269,"keywords":290,"overallStatus":52,"whyStopped":37,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":315},{"fullName":5,"class":6},"A2 Biotherapeutics Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: A2B694","EXPERIMENTAL","Patients receive preconditioning lymphodepletion (PCLD) regimen followed by a single dose of A2B694 intravenously on day 0",[13,14],"Biological: A2B694","Diagnostic Test: xT CDx with HLA-LOH Assay",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm 2: A2B543","Patients receive preconditioning lymphodepletion (PCLD) regimen followed by a single dose of A2B543 intravenously on day 0",[19,14],"Biological: A2B543",[21,28,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","A2B694","Autologous logic-gated Tmod CAR T cells",[9],[27],"Tmod CAR T-cell Therapy",{"type":22,"name":29,"description":24,"armGroupLabels":30,"otherNames":31},"A2B543",[16],[27],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DIAGNOSTIC_TEST","xT CDx with HLA-LOH Assay","An investigational next generation sequencing (NGS) in vitro diagnostic (IVD) medical device",[9,16],null,[39],{"name":40,"affiliation":41,"role":42},"John Welch, MD, PhD","A2 Biotherapeutics","STUDY_DIRECTOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":37,"email":48},"Clinical Trials","CONTACT","310-431-9180","ClinicalTrials@a2bio.com",[50,71,87,102,117,133,148,164,181,196,213,230],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Banner Health","RECRUITING","Gilbert","Arizona","85234","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-111.78903,33.35283,{"lat":62,"lon":61},[65,68],{"name":66,"role":46,"phone":37,"phoneExt":37,"email":67},"Yasmin Adam","Yasmin.Adam2@bannerhealth.com",{"name":69,"role":70,"phone":37,"phoneExt":37,"email":37},"Matthew Ulrickson, MD","PRINCIPAL_INVESTIGATOR",{"facility":72,"status":52,"city":73,"state":74,"zip":75,"country":56,"countryCode":57,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"UCSD Moores Cancer Center","La Jolla","California","92093",{"type":59,"coordinates":77},[78,79],-117.2742,32.84727,{"lat":79,"lon":78},[82,85],{"name":83,"role":46,"phone":37,"phoneExt":37,"email":84},"Jona Plevin","jplevin@health.ucsd.edu",{"name":86,"role":70,"phone":37,"phoneExt":37,"email":37},"Sandip Patel, MD",{"facility":88,"status":52,"city":89,"state":74,"zip":90,"country":56,"countryCode":57,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"UCLA Medical Center","Los Angeles","90404",{"type":59,"coordinates":92},[93,94],-118.24368,34.05223,{"lat":94,"lon":93},[97,100],{"name":98,"role":46,"phone":37,"phoneExt":37,"email":99},"Nicole Williams","NSowden@mednet.ucla.edu",{"name":101,"role":70,"phone":37,"phoneExt":37,"email":37},"J. Randolph Hecht, MD",{"facility":103,"status":52,"city":104,"state":74,"zip":105,"country":56,"countryCode":57,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Stanford University","Stanford","94305",{"type":59,"coordinates":107},[108,109],-122.16608,37.42411,{"lat":109,"lon":108},[112,115],{"name":113,"role":46,"phone":37,"phoneExt":37,"email":114},"Kayla McDaniel","mcda59@stanford.edu",{"name":116,"role":70,"phone":37,"phoneExt":37,"email":37},"Oliver Dorigo, MD",{"facility":118,"status":52,"city":119,"state":120,"zip":121,"country":56,"countryCode":57,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Mayo Clinic","Jacksonville","Florida","32224",{"type":59,"coordinates":123},[124,125],-81.65565,30.33218,{"lat":125,"lon":124},[128,131],{"name":129,"role":46,"phone":37,"phoneExt":37,"email":130},"Rhoda Romain","Romain.Rhoda@mayo.edu",{"name":132,"role":70,"phone":37,"phoneExt":37,"email":37},"Yanyan Lou, 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PhD",{"facility":165,"status":52,"city":166,"state":167,"zip":168,"country":56,"countryCode":57,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Washington University","St Louis","Missouri","63110",{"type":59,"coordinates":170},[171,172],-90.19789,38.62727,{"lat":172,"lon":171},[175,177,179],{"name":176,"role":46,"phone":37,"phoneExt":37,"email":37},"Amberly Scott",{"name":37,"role":46,"phone":37,"phoneExt":37,"email":178},"amberly@wustl.edu",{"name":180,"role":70,"phone":37,"phoneExt":37,"email":37},"Jeffery Ward, MD",{"facility":182,"status":52,"city":183,"state":183,"zip":184,"country":56,"countryCode":57,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"NYU Langone Medical Center","New York","10016",{"type":59,"coordinates":186},[187,188],-74.00597,40.71427,{"lat":188,"lon":187},[191,194],{"name":192,"role":46,"phone":37,"phoneExt":37,"email":193},"Peter Warren","Peter.Warren@nyulangone.org",{"name":195,"role":70,"phone":37,"phoneExt":37,"email":37},"Salman Punekar, MD",{"facility":197,"status":52,"city":198,"state":199,"zip":200,"country":56,"countryCode":57,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"The Ohio State University Comprehensive Cancer Center","Columbus","Ohio","43210",{"type":59,"coordinates":202},[203,204],-82.99879,39.96118,{"lat":204,"lon":203},[207,211],{"name":208,"role":46,"phone":209,"phoneExt":37,"email":210},"Dudbeth Brown","614-685-7034","Dudbeth.Brown@osumc.edu",{"name":212,"role":70,"phone":37,"phoneExt":37,"email":37},"Jinesh Gheeya, MD, PhD",{"facility":214,"status":52,"city":215,"state":216,"zip":217,"country":56,"countryCode":57,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":59,"coordinates":219},[220,221],-86.78444,36.16589,{"lat":221,"lon":220},[224,228],{"name":225,"role":46,"phone":226,"phoneExt":37,"email":227},"Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)","1-800-811-8480","CTIP@VUMC.ORG",{"name":229,"role":70,"phone":37,"phoneExt":37,"email":37},"Cathy Eng, M.D., FACP, FASCO",{"facility":231,"status":52,"city":232,"state":233,"zip":234,"country":56,"countryCode":57,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":59,"coordinates":236},[237,238],-122.33207,47.60621,{"lat":238,"lon":237},[241,243,245],{"name":242,"role":46,"phone":37,"phoneExt":37,"email":37},"Shelby Colden",{"name":37,"role":46,"phone":37,"phoneExt":37,"email":244},"scolden2@fredhutch.org",{"name":246,"role":70,"phone":37,"phoneExt":37,"email":37},"David Zhen, MD",{"type":248,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[250],{"name":251,"class":6},"Tempus AI","100520064",false,"NCT06051695","A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","A Seamless Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Autologous Logic-gated Tmod™ CAR T Products, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","EVEREST-2","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\\*02 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, OVCA, MESO, or other solid tumors with MSLN expression. Measurable disease is required with lesions of ≥1.0 cm by CT.\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long term safety follow up\n\nKey Exclusion Criteria:\n\n1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. MESO with pleural involvement extending into the peritoneum\n5. Cancer therapy within 3 weeks or 3 half lives of infusion\n6. Radiotherapy within 28 days of infusion\n7. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n8. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated\n9. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year\n10. Requires supplemental home oxygen\n11. Females of childbearing potential who are pregnant or breastfeeding\n12. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion","ALL","18 Years",{"count":262,"type":263},474,"ESTIMATED","INTERVENTIONAL",[266,267],"PHASE1","PHASE2","The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\\*02 expression.\n\nThe main questions this study aims to answer are:\n\nPhase 1: What is the recommended dose that is safe for patients\n\nPhase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells\n\nParticipants will be required to perform study procedures and assessments, and will also receive the following study treatments:\n\nEnrollment and Apheresis in BASECAMP-1 (NCT04981119)\n\nPreconditioning Lymphodepletion (PCLD) Regimen\n\nTmod CAR T cells at the assigned dose",[270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289],"Solid Tumor, Adult","Colorectal Cancer","NSCLC","Non Small Cell Lung Cancer","NSCLC, Recurrent","Non-Small Cell Squamous Lung Cancer","Pancreas Cancer","Pancreatic Neoplasm","Colorectal Adenocarcinoma","CRC","Colon Cancer","Rectal Cancer","Cancer","Ovarian Cancer","Ovarian Neoplasms","Mesothelioma","Mesothelioma, Malignant","Ovary Cancer","Lung Cancer","MESOM",[291,292,293,294,295,296,297,298,299,300,301,302,282,303,279,271,288,272,304,289,283,285,305],"CAR T Cell","Solid Tumors","Autologous","T Cell","Mesothelin","MSLN","HLA-A2","Solid Tumors expressing MSLN","Pancreatic","Cell Therapy","Gene Therapy","blocker","PANC","OVCA","Logic-gate","2026-06-10",{"date":308,"type":309},"2026-06-12","ACTUAL",{"date":311,"type":309},"2024-04-03",{"date":313,"type":263},"2029-06",{"name":5,"class":6},12]