NCT06971614 · ImmVira Pharma Co. Ltd
A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC
What this study is about
This is a Phase II clinical study to evaluate the effectiveness and safety of intravesical T3011 injection in participants with BCG-unresponsive high-risk NMIBC or BCG-exposed, chemotherapy-unresponsive intermediate/high-risk NMIBC.
View original scientific description
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.
Interventions
BIOLOGICAL
T3011
T3011 will be administered at a dose of 1x10\^10 PFU intravesically.
Primary outcome measures
Complete Response Rate in patients with CIS
Time frame: 3,6,12 months time point from the date of the first dose of T3011
Recurrence Free Survival Rate in patients with Ta/T1 (without CIS)
Time frame: 3,6,12 months time point from the date of the first dose of T3011
Incidence rates of Grade ≥3 treatment-related adverse events (TRAEs)
Time frame: 24 months
Incidence rates of TRAEs leading to treatment discontinuation, dose modification or treatment interruption.
Time frame: 24 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. 6. Labo
Where
- Queen Creek, Arizona
- Tampa, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 23, 2025 · Source of record for eligibility and locations