NCT07283835

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Lepu Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Cretostimogene Grenadenorepvec	Engineered Oncolytic Adenovirus
OTHER	n-dodecyl-B-D-maltoside	Transduction-enhancing agent

Timeline

• Start date: 2025-12-04
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-12-16
• Last updated: 2026-01-21

Locations

15 sites across 1 country: China

Regulatory

• FDA-regulated drug study