[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CG Oncology, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,38],{"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":4,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":19,"conditions":20,"keywords":25,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":34,"locationsCount":37},"100550197","an-expanded-access-program-of-cretostimogene-grenadenorepvec-for-treatment-of-nmibc-for-patients-unresponsive-to-bcg-100550197",false,"NCT06443944","An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG","An Expanded Access Program of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)","Inclusion Criteria:\n\n1. Have pathologically confirmed BCG unresponsive CIS. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols. Specifically, the definition of BCG unresponsive CIS will also require the following:\n\n   * Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease)\n   * Completion of qualifying BCG treatment (e.g., \"5+2\" minimum exposure) within 15 months of the initial qualifying dose of BCG.\n2. Have all Ta and\u002For T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment\n3. Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.\n4. Acceptable baseline organ function\n\nExclusion Criteria:\n\n1. Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer.\n2. Has had active autoimmune or inflammatory disease requiring systemic treatment within 4 weeks of Day 1. Replacement therapy is not considered an excluded form of systemic treatment and is allowed.\n3. Has received systemic anticancer therapy, including investigational agents, within 4 weeks of Day 1\n4. Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 1 week after the last study treatment.","ALL","18 Years","EXPANDED_ACCESS","This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta\u002FT1) unresponsive to BCG.",[21,22,23,24],"Non-Muscle Invasive Bladder Cancer","Urothelial Carcinoma","Urologic Cancer","Bladder Cancer",[26,24,27,28],"Urology","Non Muscle Invasive Bladder Cancer","Cretostimogene Grenadenorepvec","AVAILABLE","2026-04-13",{"date":32,"type":33},"2026-04-14","ACTUAL",{"name":35,"class":36},"CG Oncology, Inc.","INDUSTRY",26,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100559715","phase-2-phase-2-study-to-evaluate-safety-and-efficacy-of-cretostimogene-grenadenorepvec-in-high-risk-nmibc-100559715","NCT06567743","Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC","A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)","Cohort A Key Inclusion Criteria:\n\n* Pathologically confirmed BCG-naïve high-risk high-grade NMIBC (i.e., CIS with or without Ta\u002FT1 disease or high-grade Ta\u002FT1 papillary-only disease without CIS) within 90 days of treatment allocation.\n* All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.\n* Acceptable baseline organ function.\n\nCohort B Key Inclusion Criteria:\n\n* Pathologically confirmed BCG-exposed high-risk high-grade NMIBC (i.e., CIS with or without Ta\u002FT1 disease or high-grade Ta\u002FT1 papillary-only disease without CIS) within 90 days of treatment allocation.\n* All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.\n* Acceptable baseline organ function.\n\nCohort CX Inclusion Criteria\n\n* Pathologically confirmed high-risk high-grade BCG-unresponsive or BCG-exposed NMIBC (i.e., CIS with or without Ta\u002FT1 disease or high-grade Ta\u002FT1 papillary-only disease without CIS) within 90 days of treatment allocation.\n* All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.\n* Acceptable baseline organ function.\n\nKey Exclusion Criteria (Both Cohorts):\n\n* Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer.\n* High-grade urothelial carcinoma in the upper urinary tract or prostatic urethra within 24 months or T2 in upper tract within 48 months or any history of locally advanced\u002F nodal or metastatic disease in the upper urinary tract.\n* Significant immunodeficiency.\n* Pregnant or breastfeeding.\n* Cohort CX Only: serial intravesical gemcitabine within 24 months",{"count":46,"type":47},325,"ESTIMATED","INTERVENTIONAL",[50],"PHASE2","This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.",[53],"High-Risk Non-Muscle-Invasive Bladder Cancer",[24],"RECRUITING","2026-04-06",{"date":58,"type":33},"2026-04-08",{"date":60,"type":33},"2024-09-16",{"date":62,"type":47},"2027-12-30",{"name":35,"class":36},65,""]