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

NCT06971614 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-07-23

No results posted yet for this study

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.

Conditions

  • Nonmuscle-invasive Bladder Cancer

Interventions

BIOLOGICAL

T3011

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

Sponsors & Collaborators

  • ImmVira Pharma Co. Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-09
Primary Completion
2028-12-31
Completion
2029-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06971614 on ClinicalTrials.gov