Tests cretostimogene in bladder cancer that did not respond to BCG treatment
Tests cretostimogene in adults with high-risk bladder cancer that did not respond to BCG.
Plain-language title generated from the registry record
Registry title: Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Key facts
- Where
- Beijing, Changsha, Chengdu, Chongqing, Fuzhou, Hangzhou, Jinan, Nanjing, Shanghai, Shenyang, Tianjin, Wenzhou, and Wuhan, ChinaSee the 14 sites
- Phase
- Phase 2
Where in China
- Peking University First Hospital (First Clinical Medical School of Peking University)Beijing, ChinaTaking people
- Hunan Cancer HospitalChangsha, ChinaTaking people
- West China Hospital，Sichuan UniversityChengdu, ChinaTaking people
- Chongqing University Cancer HospitalChongqing, ChinaTaking people
- Fujian Cancer HospitalFuzhou, ChinaTaking people
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
- Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
- The Affiliated Drum Tower Hospital of Nanjing University Medical SchoolNanjing, ChinaTaking people
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
- Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghai, ChinaTaking people
- The First Hospital of China Medical UniversityShenyang, ChinaTaking people
- The Second Hospital of Tianjin Medical UniversityTianjin, ChinaTaking people
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lepu Biopharma Co., Ltd.
- Trial code
- NCT07283835
- Record updated
- 23 April 2026
- Original description
This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.Read full original descriptionShow less
A Single-arm, Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Cretostimogene Grenadenorepvec in Patients With BCG-unresponsive High-risk Non-Muscle Invasive Bladder Cancer
This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.
Inclusion: In order to be eligible for participation in this trial, the patient must:; Be ≥18 years of age on day of signing informed consent; Patients must have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without concomitant Ta/T1 papillary disease; Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment; Demonstrate adequate organ function; Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial; Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment.
Exclusion: History of urothelial carcinoma in the upper genitourinary tract (kidney, renal collecting system, ureter) or in the prostatic urethra, including urethral CIS, within 24 months prior to enrollment; Has received systemic anti-cancer therapy, including investigational agents; Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies; Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure; Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer; Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.