NCT06971614

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: ImmVira Pharma Co. Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In Cohort A, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (CIS with or without Ta or T1 papillary) which is unresponsive to BCG treatment. In Cohort B, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (Ta/T1 papillary without CIS) which is unresponsive to BCG treatment. In Cohort C, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (CIS with or without Ta or T1 papillary) which has previously been exposed to BCG and is unresponsive to chemotherapy treatment. In Cohort D, participants will be enrolled with pathologically confirmed intermediate/high-risk non-muscle invasive bladder cancer (NMIBC) (Ta/T1 papillary without CIS) which has previously been exposed to BCG and is unresponsive to chemotherapy treatment. In all cohorts, study treatment will be administered as a weekly induction course for the first 6 weeks. For high-risk participants, a reinduction course administered to participants who have residual CIS or high-grade Ta disease at the 3-month evaluation. Following induction, If the tumor assessment indicates CR or no recurrence the participant enters the maintenance phase, T3011 is administered once every 3 weeks (Q3W). For intermediate-risk participants, a reinduction course administered to participants who have low-grade Ta disease at the 3-month evaluation. Following induction, the participant achieving no recurrence (e.g., no tumor) enters the maintenance phase, T3011 is administered once every 3 weeks (Q3W). Disease status will be assessed using cystoscopy, urine cytology, histopathology (if performed), and imaging examinations (if performed) every 3 months during treatment period or until disease recurrence.

Conditions

• Nonmuscle-invasive Bladder Cancer

Interventions

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

Timeline

• Start date: 2025-06-09
• Primary completion: 2028-12-31
• Completion: 2029-05-31
• First posted: 2025-05-14
• Last updated: 2025-07-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study