Nonmuscle-invasive Bladder CancerPhase 2NCT06971614
A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC
A Phase 2 study testing T3011 in people with Nonmuscle-invasive Bladder Cancer, run by ImmVira Pharma Co. Ltd at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonmuscle-invasive Bladder Cancer
- What is being tested?
- T3011
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 9 sitesUnited States
- Study dates
- 9 Jun 2025to 31 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants may enter the study only if they meet all the following criteria:
- Male or female, aged ≥18 years at the time of signing the ICF.
- The participants will need to meet the following criteria:
- Participants with a histologically confirmed diagnosis of NMIBC (Ta, T1 and/or Cis).
- During the study, the participants must voluntarily comply with the study-specified cystoscopy, urine cytology and randomized biopsy.
- 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.
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Expected survival ≥24 weeks.
- Laboratory test values meeting the following requirements :
- Hematology ANC≥1.5×10^9/L. PLT count ≥75×10^9/L. Hemoglobin (HGB) ≥90 g/L.
- Renal function Creatinine clearance ≥60 mL/min (based on Cockcroft-Gault equation for calculation)
- Hepatic function Serum total bilirubin (TBIL) ≤1.5×ULN. Asparate aminotransferase (AST) and alanine transaminase (ALT) ≤2.5×ULN Serum ALB ≥30 g/L.
- Coagulation function International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN. Activated partial thromboplastin time (aPTT) ≤1.5×ULN.
- For women of childbearing potential (WOCBP), the serum pregnancy test prior to the first dose must be negative and the potential participant must promise to use medically acceptable and effective methods of contraception. after signing the ICF until at least 6 months after the last dose.
- Male participants of child-bearing potential must agree to use medically acceptable and effective methods of contraception after signing the ICF until at least 6 months after the last dose; in addition, male potential participants must agree not to donate sperm during this period.
- Participants who understand and voluntarily sign the written ICF and are willing and able to comply with all trial requirements.
Who cannot join
- Participants meeting any of the following criteria will not be allowed to participate in this study:
- Participants meet the following criteria:
- Concurrent or prior history of muscle-invasive (muscularis propria) or metastatic bladder cancer.
- Urothelial carcinoma of the upper genitourinary tract or prostatic urethra within 24 months prior to investigational product.
- Having received chemotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, investigational product or other anti-neoplastic therapies within 4 weeks prior to investigational product.
- Having received radiotherapy within 2 weeks prior to investigational product.
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- Planning to receive any anti-neoplastic therapy other than the investigational products during this study.
- 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.
- A history of brain metastasis or imaging-confirmed brain metastasis , leptomeningeal disease, or spinal cord compression.
- Concurrent or prior history of other malignancies than that treated in this study.
- History or evidence of high-risk cardiovascular diseases, including but not limited to:
- Serious cardiac rhythm or conduction abnormalities.
- Acute myocardial infarction, unstable angina, or stroke, etc., developing within 6 months prior to the first dose of the investigational products.
- Coronary angioplasty or stenting within 6 months prior to the first dose of the investigational products.
- New York Heart Association (NYHA) criteria-defined cardiac function > Class II; echocardiogram-documented cardiac valve morphological abnormalities (Grade ≥2).
- Left ventricular ejection fraction (LVEF) ˂lower limit of normal (LLN) of the study site, or ˂ 50% if no LLN is set at the site.
- Poorly controlled blood pressure .
- The following prior or concurrent immune disorders that in the investigator's opinion would pose unpredictable risks to the participants:
- Immune-related pneumonia or other immune-related adverse reactions of Grade ≥3 developing with prior immunotherapy (including but not limited to PD-1/PD-L1).
- Concurrent active immune diseases requiring treatment with systemic immunosuppressants (excluding autoimmune diseases not requiring intervention such as vitiligo and diseases treatable by other alternative drugs such as hypothyroidism that is treated with thyroid hormone replacement therapy originally), or concurrent immune diseases requiring treatment with systemic immunosuppressants that have the potential to recurrence (e.g., systemic lupus erythematosus).
- Other concurrent diseases require treatment with systemic immunosuppressants.
- Unexplainable fever >38.5℃ during the screening or on the day of treatment (fever judged as tumor-induced by the investigator is eligible for enrollment) that in the investigator's opinion will affect the participation in this trial or interfere with the efficacy assessment.
- The following persistent or active infections: human immunodeficiency virus (HIV) antibody-positive, hepatitis B surface antigen [HBsAg] positive with HBV DNA level ≥2000 IU/mL, hepatitis C virus (HCV) antibody positive with detectable HCV RNA, and other active infections requiring systemic treatment.
- Prior history of splenectomy or organ transplantation.
- Having previously received treatment with oncolytic virus (e.g., T-VEC, CG0070).
- Requiring oral or intravenous use of anti-herpes virus drugs, including but not limited to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, and cidofovir (except for those to be used locally, such as topically), during the study.
- Participants with known psychiatric disorders that may affect compliance in trial or with poor compliance.
- Participants with a history of drug abuse (including "recreational use") or substance abuse (including alcohol) within one year prior to signing ICF.
- Being pregnant or breast feeding, or planning to become pregnant or give birth during this trial.
- Having received any live attenuated vaccine within 4 weeks prior to investigational product or planning to receive such vaccines during the study.
- Having undergone a major surgery.
- Any diseases that at the investigator's discretion may confound the trial results, interfere with the participation in the entire trial, and/or would make participating in the trial not in the participant's best interest, or a medical history with treatment or laboratory abnormalities, or any other circumstances that would make it inappropriate for the participant to be enrolled.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Alberto Martini, MD
- Recruiting
Tower Urology
Los Angeles, California, 90048
David Josephson, MD
- Recruiting
Helios Clinical Research
Middleburg Heights, Ohio, 44130
Lawrence Gervasi, MD
- Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Neal Shore, MD
- Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Vignesh Packiam, MD
- Recruiting
Advent Health Medical Group Urology
Orlando, Florida, 32803
Zachary Smith, MD
- Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Shifeng Mao, MD
- Recruiting
East Valley Urology Center
Queen Creek, Arizona, 85140
Harpreet Wadhwa, MD
- Recruiting
Florida Urology Partners, LLP
Tampa, Florida, 33615
Osvaldo Padron, MD
About this study
Official title: An Open-Label, International, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Intravesical T3011 Injection in Participants With BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) or BCG-Exposed, Chemotherapy-Unresponsive Intermediate /High-Risk NMIBC
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.
Read the detailed description
In Cohort A, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (CIS with or without Ta or T1 papillary) which is unresponsive to BCG treatment.
In Cohort B, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (Ta/T1 papillary without CIS) which is unresponsive to BCG treatment.
In Cohort C, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (CIS with or without Ta or T1 papillary) which has previously been exposed to BCG and is unresponsive to chemotherapy treatment.
In Cohort D, participants will be enrolled with pathologically confirmed intermediate/high-risk non-muscle invasive bladder cancer (NMIBC) (Ta/T1 papillary without CIS) which has previously been exposed to BCG and is unresponsive to chemotherapy treatment.
In all cohorts, study treatment will be administered as a weekly induction course for the first 6 weeks.
For high-risk participants, a reinduction course administered to participants who have residual CIS or high-grade Ta disease at the 3-month evaluation. Following induction, If the tumor assessment indicates CR or no recurrence the participant enters the maintenance phase, T3011 is administered once every 3 weeks (Q3W).
For intermediate-risk participants, a reinduction course administered to participants who have low-grade Ta disease at the 3-month evaluation. Following induction, the participant achieving no recurrence (e.g., no tumor) enters the maintenance phase, T3011 is administered once every 3 weeks (Q3W).
Disease status will be assessed using cystoscopy, urine cytology, histopathology (if performed), and imaging examinations (if performed) every 3 months during treatment period or until disease recurrence.
- Conditions
- Nonmuscle-invasive Bladder Cancer
- Being tested
- T3011
- Keywords
- Nonmuscle-invasive Bladder Cancer, Herpes Virus T3011 Injection, BCG-Unresponsive, BCG-Exposed, Chemotherapy-Unresponsive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3011Biological
T3011 will be administered at a dose of 1x10^10 PFU intravesically.
| Study group | Role | What they receive |
|---|---|---|
| T3011 | Experimental | 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. Receives: Biological: T3011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate in patients with CIS
Measured: 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)
Measured: 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)
Measured: 24 months
Incidence rates of TRAEs leading to treatment discontinuation, dose modification or treatment interruption.
Measured: 24 months
Secondary outcomes (3)
Complete Response Rate in patients with CIS
Measured: 18,24 months time point from the date of the first dose of T3011
Recurrence Free Survival Rate in patients with Ta/T1 (without CIS)
Measured: 18,24 months time point from the date of the first dose of T3011
Safety Endpoints
- Incidence rates of Grade ≥3 treatment-emergent adverse events (TEAEs)
- Incidence rates of all grades of TRAEs
- Incidence rates of AEs leading to treatment discontinuation, dose modification or treatment interruption
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start9 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonmuscle-invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmVira Pharma Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971614
- Sponsor's protocol ID
- MVR-T3011-006
- Status last verified
- Aug 2026
- First submitted
- 27 Apr 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, International, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Intravesical T3011 Injection in Participants With BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) or BCG-Exposed, Chemotherapy-Unresponsive Intermediate /High-Risk NMIBC
- ClinicalTrials.gov ID
- NCT06971614
- Acronym / sponsor ID
- MVR-T3011-006
- Conditions
- Nonmuscle-invasive Bladder Cancer
- Keywords
- Nonmuscle-invasive Bladder Cancer, Herpes Virus T3011 Injection, BCG-Unresponsive, BCG-Exposed, Chemotherapy-Unresponsive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- ImmVira Pharma Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In Cohort A, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (CIS with or without Ta or T1 papillary) which is unresponsive to BCG treatment.
In Cohort B, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (Ta/T1 papillary without CIS) which is unresponsive to BCG treatment.
In Cohort C, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (CIS with or without Ta or T1 papillary) which has previously been exposed to BCG and is unresponsive to chemotherapy treatment.
In Cohort D, participants will be enrolled with pathologically confirmed intermediate/high-risk non-muscle invasive bladder cancer (NMIBC) (Ta/T1 papillary without CIS) which has previously been exposed to BCG and is unresponsive to chemotherapy treatment.
In all cohorts, study treatment will be administered as a weekly induction course for the first 6 weeks.
For high-risk participants, a reinduction course administered to participants who have residual CIS or high-grade Ta disease at the 3-month evaluation. Following induction, If the tumor assessment indicates CR or no recurrence the participant enters the maintenance phase, T3011 is administered once every 3 weeks (Q3W).
For intermediate-risk participants, a reinduction course administered to participants who have low-grade Ta disease at the 3-month evaluation. Following induction, the participant achieving no recurrence (e.g., no tumor) enters the maintenance phase, T3011 is administered once every 3 weeks (Q3W).
Disease status will be assessed using cystoscopy, urine cytology, histopathology (if performed), and imaging examinations (if performed) every 3 months during treatment period or until disease recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T3011 | Experimental | Biological: T3011T3011 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female, aged ≥18 years at the time of signing the ICF.
- The participants will need to meet the following criteria:
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Expected survival ≥24 weeks.
Key exclusion criteria (32 listed)
- Participants meeting any of the following criteria will not be allowed to participate in this study:
- Participants meet the following criteria:
- Planning to receive any anti-neoplastic therapy other than the investigational products during this study.
- 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.
- A history of brain metastasis or imaging-confirmed brain metastasis , leptomeningeal disease, or spinal cord compression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T3011T3011 will be administered at a dose of 1x10^10 PFU intravesically. | Biological | T3011 |
Primary outcome
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
3 secondary outcomes
Complete Response Rate in patients with CIS
Time frame: 18,24 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: 18,24 months time point from the date of the first dose of T3011
Safety Endpoints
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Nonmuscle-invasive Bladder Cancer
Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
Active, not recruitingPhase 2
Intravesical Gem/Doce in Patients With NMIBC
Urinary Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing T3011 in people with Nonmuscle-invasive Bladder Cancer, run by ImmVira Pharma Co. Ltd at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasmine Yang (86-512-66202028, xu.yang@immviragroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.