RecruitingNonmuscle-invasive Bladder Cancer
A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
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About this study
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.
Sponsor: ImmVira Pharma Co. Ltd
You may qualify if…
- ✓ Participants may enter the study only if they meet all the following criteria:
- ✓ 1. Male or female, aged ≥18 years at the time of signing the ICF.
- ✓ 2. The participants will need to meet the following criteria:
- ✓ 1. Participants with a histologically confirmed diagnosis of NMIBC (Ta, T1 and/or Cis).
- ✓ 2. During the study, the participants must voluntarily comply with the study-specified cystoscopy, urine cytology and randomized biopsy.
- ✓ 3. All toxicities caused by prior radiotherapy, chemotherapy or other treatments have recovered to Grade ≤1 (CTCAE 5.0) (except for alopecia), including but not limited to urinary tract infection, urinary tract irritation, and macroscopic hematuria; participants with Grade \>1 anti-neoplastic treatment-related toxicities during the screening period may be enrolled after discussion of the investigators and the sponsor.
- ✓ 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- ✓ 5. Expected survival ≥24 weeks.
You may not qualify if…
- ✕ Participants meeting any of the following criteria will not be allowed to participate in this study:
- ✕ 1. Participants meet the following criteria:
- ✕ 1. Concurrent or prior history of muscle-invasive (muscularis propria) or metastatic bladder cancer.
- ✕ 2. Urothelial carcinoma of the upper genitourinary tract or prostatic urethra within 24 months prior to investigational product.
- ✕ 3. Having received chemotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, investigational product or other anti-neoplastic therapies within 4 weeks prior to investigational product.
- ✕ 4. Having received radiotherapy within 2 weeks prior to investigational product.
- ✕ 2. Planning to receive any anti-neoplastic therapy other than the investigational products during this study.
- ✕ 3. A history of allergic reactions to HSV-1, IL-12, or anti-PD-1 antibodies or biological components similar to them, or known allergic reactions to any component of the T3011 formulation.
Where it's recruiting
Arizona
Queen Creek
California
Los Angeles
Florida
Orlando · Tampa
New Jersey
New Brunswick
Ohio
Cincinnati · Middleburg Heights
Pennsylvania
Pittsburgh
South Carolina
Myrtle Beach
Source: ClinicalTrials.gov · NCT06971614 · last updated 2026-08-18