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

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

First listed

May 14, 2025

Start date

Jun 9, 2025

Status verified

Aug 2026

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

• Jasmine Yang
  86-512-66202028
  [email protected]

Locations (9)

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