[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627103":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":59,"collaborators":28,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":28,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":28,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":43,"whyStopped":28,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Shanghai AbelZeta Ltd.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"C-CAR031 Cohort 1","EXPERIMENTAL","Dose Level 1 at 0.75mpk C-CAR031 to be infused to subjects",[13],"Drug: C-CAR031",{"label":15,"type":10,"description":16,"interventionNames":17},"C-CAR031 Cohort 2","Dose Level 2 at 1.5mpk C-CAR031 to be infused to subjects",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"C-CAR031 Cohort 3","Dose Level 3 at 4.0mpk C-CAR031 to be infused to subjects",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","C-CAR031","C-CAR031 is an autologous CAR T-cell product that expresses a CAR specific for GPC3 and a dominant-negative transforming growth factor-beta receptor II (dnTGFβRII).",[9,15,19],null,[30],{"name":31,"affiliation":32,"role":33},"Shun Lu, MD","Shanghai Chest Hospital, China","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"Yinghua Shen","CONTACT","+86-18616644879","yinghua.shen@abelzeta.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":28,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Shanghai Chest Hospital","RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":28,"email":58},"Ziming Li, MD","+86-21-62821990","liziming1980@hotmail.com",{"type":60,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100627103","phase-1-an-phase-i-trial-of-a-car-t-cell-infusion-c-car031-in-participants-with-gpc3-advancedmetastatic-squamous-cell-lung-cancer-100627103",false,"NCT07444281","An Phase I Trial of a CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced\u002FMetastatic Squamous Cell Lung Cancer","An Investigator-initiated Phase I Trial of an Armored and GPC3-targeted Autologous CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced\u002FMetastatic Squamous Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable Stage IIIB ,IIIC or IV squamous cell lung cancer\n* Confirmed to express GPC3, as assessed by immunohistochemistry at a central lab\n* Participants who have progressed or intolerant to no more than three lines of prior systemic therapies for advanced\u002Fmetastatic squamous cell lung cancer\n* At least one measurable target lesion\n* The left ventricular ejection fraction (LVEF) measured by echocardiography ≥50% and reported as non-impaired.\n* Sufficient pulmonary function\n* The laboratory testing results meet the study requirements\n* Female participants of childbearing potential must test negative for pregnancy in serum or urine. Non-sterilized participants (males and females) agree to take effective contraceptive measures for at least 12 months and until CAR-T below lower limit of detection (LLOD) by PCR which occurs last after C-CAR031 infusion.\n\nExclusion Criteria:\n\n* known to harbor a driver mutation for which targeted standard therapy is recommended in accordance with local treatment guidelines.\n* Known life-threatening allergies, hypersensitivity, or intolerance to the CAR-T product or its excipients, including dimethyl sulfoxide (DMSO)\n* Contraindication to lymphodepleting agents, including fludarabine and\u002For cyclophosphamide.\n* History of splenectomy or organ transplantation\n* Prior treatment with Any CAR-T therapy OR any therapy that is targeting GPC3\n* Uncontrolled or intercurrent pulmonary disease\n* Clinically meaningful ascites\n* Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures\n* Cancer-related spinal cord compression, leptomeningeal disease, or brain metastases\n* Received radiation therapy, local treatment, vaccine, blood transfusion, systemic treatment within certain period of apheresis required by study protocol\n* History of or with active diseases or conditions of that's defined in study protocol","ALL","18 Years","75 Years",{"count":72,"type":73},24,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","This single-arm, open-label, multicenter, Phase I study will evaluate the safety, tolerability, anti-tumor activity, pharmacokinetics (PK)\u002Fpharmacodynamics (PD), biomarker, and immunogenicity of C-CAR031 in adult participants with GPC3+ advanced\u002Fmetastatic squamous cell lung cancer, who are not amenable to curative therapy and have progressed or are intolerant to no more than 3 lines of prior systemic treatment including immune checkpoint inhibitors (CPIs) and platinum-based doublet chemotherapy, concurrently or sequentially.",[79],"Squamous Cell Lung Cancer",[81,82,83],"squamous cell lung cancer","advanced squamous cell lung cancer","metastatic squamous cell lung cancer","2026-02-27",{"date":86,"type":87},"2026-03-03","ACTUAL",{"date":89,"type":87},"2024-12-25",{"date":91,"type":73},"2028-01-30",{"name":5,"class":6},1]