[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651819":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":25,"locations":11,"responsibleParty":31,"collaborators":11,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":18,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":11,"studyType":46,"phases":47,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":56,"whyStopped":11,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":11},{"fullName":5,"class":6},"Gritbio Medicine, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with advanced solid tumors","EXPERIMENTAL",null,[13,14],"Biological: GT201","Biological: IL-2 and PD-1",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"BIOLOGICAL","GT201","A tumor sample from individual participant is collected through a surgical resection for ex vivo manufacturing of GT201 TIL cell product.",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"IL-2 and PD-1","Participants tandemly receives a lymphodepleting regimen, GT201 TIL product, and IL-2. Some participants may also receive a PD-1 inhibitor following GT201 infusion",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Gritbio Study Team","CONTACT","440-414-3338","GT201.inquiries@grit-bio.com",{"type":32,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100651819","phase-1-autologous-tumor-infiltrating-lymphocyte-til-gt201-infusion-100651819",false,"NCT07766317","Autologous Tumor Infiltrating Lymphocyte (TIL) GT201 Infusion.","A Phase I\u002FII Open-Label Clinical Study of Autologous Tumor Infiltrating Lymphocyte Infusion (GT201) in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\nKey eligibility criteria for inclusion in the study:\n\n* 1 Age 18\\~70 years old;\n* 2 Diagnosed with: Phase 1 part: Patients with advanced solid tumors who have failed all standard therapy, have no standard therapy, or are intolerant of standard therapy Phase 2a part: Patients with an advanced or metastatic solid tumor enrolled in one of three (3) indications selected for dose expansion based on Phase 1 safety and preliminary activity. Patients must have progressed on or after standard-of-care therapy, or for whom no suitable standard therapy is available;\n* 3 At least one lesion that is resectable for the preparation of autologous TIL cells;\n* 4 At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling;\n* 5 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n* 6 Expected survival ≥ 12 weeks;\n* 7 Non-surgically sterilized women of reproductive age who agree to use at least one medically recognized method of contraception during the study treatment period and for 1 year after the end of the study treatment period; and must have a negative serum test at screening, prior NMA-LD and cell infusion.\n\nExclusion Criteria:\n\nSubjects will be excluded from the study for one or more of the following conditions:\n\n* 1 Patients with spinal cord compression that has failed to resolve after surgery and\u002For radiotherapy (patients with clinical evidence that symptoms have resolved after surgery or radiation therapy for ≥ 1 week prior to surgical sampling are eligible for enrollment);\n* 2 Bleeding events within 3 months prior to screening\n* 3 Patients with arterio-venous thrombotic events that occurred within 3 months prior to screening\n* 4 Have interstitial pneumonia or active pneumonia that is clinically significant at screening, or other respiratory conditions that severely affect lung function;\n* 5 Patients who have a left ventricular ejection fraction (LVEF) \\\u003C 45% or who are New York Heart Association (NYHA) Class grade \\> grade 2;\n* 6 Participants with ≥ 3 untreated central nervous system (CNS) metastases;\n* 7 Have any historical or active autoimmune disease requiring systemic steroids, or immunosuppressive therapy (\\> 10 mg\u002Fday of prednisone or equivalent);\n* 8 Malignant tumors other than the target indication within 5 years;\n* 9 The presence of refractory or intractable epilepsy, large amounts of pleural effusion, ascites, pericardial effusion, etc. that cannot be controlled by drugs, or other contraindications to IL-2 use;\n* 10 Patients with infectious diseases, will be excluded from the study; with some exceptions for HBV and HCV.\n* 11 Previous allogeneic bone marrow transplantation or solid organ transplantation;","ALL","18 Years","70 Years",{"count":44,"type":45},63,"ESTIMATED","INTERVENTIONAL",[48,49],"PHASE1","PHASE2","This is a multicenter, single-arm phase 1\u002F2 clinical trial to evaluate the safety and tolerability of GT201 as a monotherapy or in combination with anti-PD-1 therapy in patients with advanced solid tumors, and to evaluate the efficacy of this therapy.",[52],"Advanced Solid Tumors Cancer",[54,55],"Tumor Infiltrating Lymphocyte","TIL","NOT_YET_RECRUITING","2026-08-13",{"date":59,"type":60},"2026-08-14","ACTUAL",{"date":62,"type":45},"2026-11",{"date":64,"type":45},"2032-06",{"name":5,"class":6}]