Actively Recruiting
A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC
Led by ImmVira Pharma Co. Ltd · Updated on 2025-07-23
160
Participants Needed
2
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at the time of consent
- Histologically confirmed diagnosis of NMIBC (Ta, T1 and/or CIS)
- Willing to comply with study cystoscopy, urine cytology, and randomized biopsy requirements
- All prior treatment toxicities resolved to Grade 1 or less (except alopecia), or acceptable after investigator and sponsor discussion
- ECOG performance status score of 0 to 2
- Expected survival of at least 24 weeks
- Laboratory tests within specified limits for hematology, renal, hepatic, and coagulation function
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during and 6 months after treatment
- Male participants of childbearing potential agree to use contraception and not donate sperm during treatment and 6 months after
- Ability to understand and voluntarily sign informed consent and comply with study requirements
You will not qualify if you...
- History or current muscle-invasive or metastatic bladder cancer
- Urothelial carcinoma of upper urinary tract or prostatic urethra within 24 months prior to study drug
- Received chemotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, investigational products, or other anti-cancer treatments within 4 weeks prior to study drug
- Received radiotherapy within 2 weeks prior to study drug
- Planning to receive other anti-cancer therapies during the study
- Allergic reactions to HSV-1, IL-12, anti-PD-1 antibodies, or components of T3011
- History or presence of brain metastases, leptomeningeal disease, or spinal cord compression
- History or concurrent other malignancies not treated within this study
- High-risk cardiovascular diseases including serious arrhythmias, recent heart attack or stroke, recent coronary interventions, poor heart function, or poorly controlled blood pressure
- Certain immune disorders requiring systemic immunosuppressants or history of severe immune-related adverse reactions
- Unexplained fever above 38.5°C that may affect study participation
- Active infections including HIV, hepatitis B or C with significant viral load, or other infections needing systemic treatment
- Prior splenectomy or organ transplant
- Prior treatment with oncolytic viruses
- Need for systemic anti-herpes virus medications during the study
- Psychiatric disorders or poor compliance
- History of drug or substance abuse within one year
- Pregnant or breastfeeding or planning pregnancy during the study
- Receipt of live attenuated vaccines within 4 weeks prior to study drug or planned during the study
- Recent major surgery
- Any other condition or circumstance that might interfere with study participation or safety according to investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
East Valley Urology Center
Queen Creek, Arizona, United States, 85140
Not Yet Recruiting
2
Florida Urology Partners, LLP
Tampa, Florida, United States, 33615
Actively Recruiting
Research Team
J
Jasmine Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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