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

Part of paid clinical trials in Queen Creek, Arizona.

Sponsor
ImmVira Pharma Co. Ltd
Study ID
NCT06971614
Phase
PHASE2
Status
Recruiting
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Conditions

  • Nonmuscle-invasive Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 9, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
160 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: T3011
    T3011 will be given once a week (QW) for 6 weeks during the induction treatment course, the following 6 weeks are only for observation and then the 3-month efficacy assessment will be conducted. During the maintenance period, T3011 will be given every 3 weeks (Q3W) until about 24 months or meeting the criteria for treatment discontinuation.

Primary Outcome Measure

Complete Response Rate in patients with CIS [ Time Frame: 3,6,12 months time point from the date of the first dose of T3011 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
East Valley Urology CenterQueen CreekArizona85140
Harpreet Singh Wadhwa, MD
Florida Urology Partners, LLPTampaFlorida33615
Osvaldo Padron, MD

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