RecruitingPhase 2NCT07283835

Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

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

Sponsor

Lepu Biopharma Co., Ltd.

Enrollment

16 participants

Start Date

Dec 4, 2025

Study Type

INTERVENTIONAL

Conditions

Non Muscle Invasive Bladder Cancer High-grade Ta/ T1 Papillary Disease Bladder Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing cretostimogene grenadenorepvec, a virus-based drug injected directly into the bladder, for people with non-muscle-invasive bladder cancer that has not responded to BCG — the standard first-line treatment. **You may be eligible if...** - You are 18 or older - You have been confirmed by biopsy to have BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ (CIS) - All visible tumors have been removed or destroyed before starting treatment - Your performance status is good (ECOG 0–2) - You have adequate organ function based on lab tests - You are willing to undergo regular cystoscopies (bladder camera exams), urine tests, and biopsies as required **You may NOT be eligible if...** - Your bladder cancer has not been confirmed to be BCG-unresponsive - Your cancer has invaded the bladder muscle - You are unwilling to undergo required monitoring procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCretostimogene Grenadenorepvec

Engineered Oncolytic Adenovirus

OTHERn-dodecyl-B-D-maltoside

Transduction-enhancing agent

Locations(14)

Peking University First Hospital (First Clinical Medical School of Peking University)

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07283835

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