RecruitingPhase 2NCT06971614

A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC

An Open-Label, International, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Intravesical T3011 Injection in Participants With BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) or BCG-Exposed, Chemotherapy-Unresponsive Intermediate /High-Risk NMIBC


Sponsor

ImmVira Pharma Co. Ltd

Enrollment

160 participants

Start Date

Jun 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase II clinical study to evaluate the efficacy and safety of intravesical T3011 injection in participants with BCG-unresponsive high-risk NMIBC or BCG-exposed, chemotherapy-unresponsive intermediate/high-risk NMIBC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called T3011 — a modified virus combined with an immune-boosting molecule — injected directly into the bladder to treat early-stage bladder cancer that has not responded to standard BCG treatment (a common bladder cancer therapy). **You may be eligible if...** - You are 18 years or older - You have non-muscle-invasive bladder cancer (cancer that has not spread into the bladder wall muscle) - Your cancer has not responded to BCG treatment, or you have had chemotherapy but the cancer returned - You are physically well enough to participate (ECOG score 0–2) - Your blood counts, kidney, and liver function meet the required levels **You may NOT be eligible if...** - Your bladder cancer has spread into the muscle wall or to other parts of the body - You have had another cancer (other than this bladder cancer) - You have serious heart problems or poorly controlled blood pressure - You are HIV-positive, have active hepatitis B or C, or other active infections - You have a suppressed immune system or take immunosuppressant drugs - You are pregnant or breastfeeding - You have previously been treated with an oncolytic virus therapy 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

BIOLOGICALT3011

T3011 will be administered at a dose of 1x10\^10 PFU intravesically.


Locations(2)

East Valley Urology Center

Queen Creek, Arizona, United States

Florida Urology Partners, LLP

Tampa, Florida, United States

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NCT06971614