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

NCT06971614 | Recruiting Phase 2 FDA Drug

• 1 other identifier: MVR-T3011-006
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Nonmuscle-invasive Bladder Cancer

Keywords

Nonmuscle-invasive Bladder Cancer; Herpes Virus T3011 Injection; BCG-Unresponsive; BCG-Exposed; Chemotherapy-Unresponsive

Outcome Measures

Primary Outcomes (4)

• Complete Response Rate in patients with CIS

  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)

  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)

  24 months

• Incidence rates of TRAEs leading to treatment discontinuation, dose modification or treatment interruption.

  24 months

Secondary Outcomes (3)

• Complete Response Rate in patients with CIS

  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)

  18,24 months time point from the date of the first dose of T3011

• Safety Endpoints

  24 months

Study Arms (1)

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.

Biological: T3011

Interventions

T3011 BIOLOGICAL

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

T3011

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• ImmVira Pharma Co. Ltd: lead

Study Sites (2)

East Valley Urology Center

Queen Creek, Arizona, 85140, United States

NOT YET RECRUITING

Florida Urology Partners, LLP

Tampa, Florida, 33615, United States

RECRUITING

Central Study Contacts

Jasmine Yang

CONTACT

86-512-66202028; xu.yang@immviragroup.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 14, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)