LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve

Summary

This study will evaluate the safety and efficacy of intravesical administration of detalimogene (EG-70) in the bladder and its effect on bladder tumors in patients with NMIBC. This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is. The Study will include patients with: NMIBC with CIS for whom BCG therapy is unresponsive, and other high risk patients with NMIBC.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Superficial Bladder Cancer
• Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
• Non-muscle Invasive Bladder Cancer

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1/2

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

enGene, Inc.

Last updated on ClinicalTrials.gov

August 7, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites