[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Gritbio Medicine, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"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","GT201","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":21,"type":22},63,"ESTIMATED","INTERVENTIONAL",[25,26],"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.",[29],"Advanced Solid Tumors Cancer",[31,32],"Tumor Infiltrating Lymphocyte","TIL","NOT_YET_RECRUITING","2026-08-13",{"date":36,"type":37},"2026-08-14","ACTUAL",{"date":39,"type":22},"2026-11",{"date":41,"type":22},"2032-06",{"name":43,"class":44},"Gritbio Medicine, Inc.","INDUSTRY",""]