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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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

A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC (NCT06971614) is a Phase 2 interventional studying Nonmuscle-invasive Bladder Cancer, sponsored by ImmVira Pharma Co. Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Nonmuscle-invasive Bladder Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 160 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Nonmuscle-invasive Bladder Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 diagnosed by tissue sample (biopsy-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. Laboratory test values meeting the following requirements : 1. Hematology white blood cell count (ANC) at least 1.5×10\^9/L. PLT count ≥75×10\^9/L. Hemoglobin (HGB) ≥90 g/L. 2. Renal function kidney function (creatinine clearance) at least 60 mL/min (based on Cockcroft-Gault equation for calculation) 3. Hepatic function Serum total bilirubin (TBIL) ≤1.5×ULN. Asparate aminotransferase (AST) and alanine transaminase (ALT) ≤2.5×ULN Serum ALB ≥30 g/L. 4. Coagulation function International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN. Activated partial thromboplastin time (aPTT) ≤1.5×ULN. 7. 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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. Laboratory test values meeting the following requirements : 1. Hematology ANC≥1.5×10\^9/L. PLT count ≥75×10\^9/L. Hemoglobin (HGB) ≥90 g/L. 2. Renal function Creatinine clearance ≥60 mL/min (based on Cockcroft-Gault equation for calculation) 3. Hepatic function Serum total bilirubin (TBIL) ≤1.5×ULN. Asparate aminotransferase (AST) and alanine transaminase (ALT) ≤2.5×ULN Serum ALB ≥30 g/L. 4. Coagulation function International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN. Activated partial thromboplastin time (aPTT) ≤1.5×ULN. 7. 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. 8. 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. 9. Participants who understand and voluntarily sign the written ICF and are willing and able to comply with all trial requirements. Exclusion Criteria: 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. 4. A history of brain metastasis or imaging-confirmed brain metastasis , leptomeningeal disease, or spinal cord compression. 5. Concurrent or prior history of other malignancies than that treated in this study. 6. History or evidence of high-risk cardiovascular diseases, including but not limited to: 1. Serious cardiac rhythm or conduction abnormalities. 2. Acute myocardial infarction, unstable angina, or stroke, etc., developing within 6 months prior to the first dose of the investigational products. 3. Coronary angioplasty or stenting within 6 months prior to the first dose of the investigational products. 4. New York Heart Association (NYHA) criteria-defined cardiac function \> Class II; echocardiogram-documented cardiac valve morphological abnormalities (Grade ≥2). 5. Left ventricular ejection fraction (LVEF) ˂lower limit of normal (LLN) of the study site, or ˂ 50% if no LLN is set at the site. 6. Poorly controlled blood pressure . 7. The following prior or concurrent immune disorders that in the investigator's opinion would pose unpredictable risks to the participants: 1. 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). 2. 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). 3. Other concurrent diseases require treatment with systemic immunosuppressants. 8. 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. 9. 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. 10. Prior history of splenectomy or organ transplantation. 11. Having previously received treatment with oncolytic virus (e.g., T-VEC, CG0070). 12. 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. 13. Participants with known psychiatric disorders that may affect compliance in trial or with poor compliance. 14. Participants with a history of drug abuse (including "recreational use") or substance abuse (including alcohol) within one year prior to signing ICF. 15. Being pregnant or breast feeding, or planning to become pregnant or give birth during this trial. 16. Having received any live attenuated vaccine within 4 weeks prior to investigational product or planning to receive such vaccines during the study. 17. Having undergone a major surgery. 18. 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.

Treatments Being Tested

BIOLOGICAL

T3011

T3011 will be administered at a dose of 1x10\^10 PFU intravesically.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

East Valley Urology Center
Queen Creek, Arizona, United States
Florida Urology Partners, LLP
Tampa, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06971614), the sponsor (ImmVira Pharma Co. Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06971614 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06971614?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06971614?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06971614. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06971614. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.