Bladder CancerPhase 1NCT06427291
Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC Patients
A Phase 1 study testing Herpes virus T3011 injection in people with Bladder Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, open-label, single-arm investigator-initiated clinical study. It is used to evaluate the safety and efficacy of T3011 intravesical instillation in patients with BCG-failure high-risk non-muscle invasive bladder cancer (NMIBC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Herpes virus T3011 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2023to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 who understand and voluntarily sign the written ICF, and are willing and able to comply with all trial requirements.
- Male or female, aged ≥ 18 years at the time of signing the ICF.
- Participants with a histologically confirmed diagnosis of NMIBC (Ta, T1 and/or Tis).
- Participants with high risk NMIBC who have been diagnosed by cystoscopy, urine cytology, and histopathology within 8 weeks prior to the first dose administration and have failed or intolerant to BCG treatment after TURBT surgery, and are not suitable or willing to undergo radical cystectomy.
- BCG-failure include BCG refractory, recurrence or relapsing after BCG treatment, BCG unresponsive and BCG intolerant.
- All tumors should have no visible tumors after transurethral bladder tumor resection (TURBT). If meeting the requirements for secondary resection, secondary resection need to be done. It is recommended to perform secondary resection if the following conditions are met: the first TURBT is insufficient, there is no muscle tissue in the first resection specimen (excluding low-grade [Ta G1] tumors and pure in situ cancers), T1 stage tumors, and high-grade [G3] tumors (excluding pure in situ cancers); Secondary resection is recommended to be performed 2-6 weeks after the first resection; Participants undergoing secondary resection must meet the requirement of no visible tumors after surgery.
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival ≥3 months.
- Sufficient hematology and terminal organ function were met within 4 weeks prior to the first s treatment, for example, having sufficient bone marrow reserves and organ function:
- Hematology (hematopoietic growth factor treatment or blood transfusion should not be given within 2 weeks prior to the treatment of study drug): 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, Aspertate aminotransferase (AST) and alanine transaminase (ALT) ≤3×ULN
- Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN; Activated partial thromboplastin time (aPTT) ≤1.5×ULN
- Women with fertility should agree to use contraceptive measures (such as intrauterine devices (IUDs), contraceptives, or condoms) during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non lactating patient; Men should agree to patients who must use contraceptive measures during the study period and within 6 months after the end of the study period. Note: A female subject with fertility is defined as a female subject who has not reached a postmenopausal state after menarche (continuous amenorrhea for at least 12 months, with no other clear cause other than menopause), and has not undergone surgery (i.e. bilateral ovariectomy, fallopian tube resection, and/or hysterectomy) or other causes determined by the researcher (such as underdeveloped Mullerian tubes) leading to permanent infertility.
Who cannot join
- Patients meeting one or more of the following criteria will be excluded:
- The diagnosis is confirmed as muscle invasive bladder cancer (T2-T4).
- Patients with concurrent upper and lower urinary tract epithelial carcinoma, lymph node metastasis, or distant metastasis.
- Pregnant and lactating female patients.
- Having major surgery within 4 weeks prior to the first dose of the study drug, or anticipate the need for major surgery rather than diagnosis after enrolling the study.
- In addition to immediate instillation therapy after TURBT surgery, anti-tumor drug treatments such as chemotherapy, radiation therapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc. have been received within 4 weeks prior to the first dose of the study drug (excluding nitroso urea, mitomycin C, oral fluorouracil, small molecule targeted drugs, and traditional Chinese medicine with anti-tumor indications). Nitrso urea or mitomycin C is within 6 weeks prior to the first use of the study drug, and oral fluorouracil and small molecule targeted drugs are within 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug (whichever is longer). Traditional Chinese medicine with anti-tumor indications is within 2 weeks prior to the first dose of the study drug.
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- Patients who have received systemic corticosteroids (prednisone>10mg/day or equivalent doses of similar drugs) or other immunosuppressive treatments within 14 days prior to the first dose of the study drug; Excluding the use of local, ocular, intra-articular, intranasal, and inhaled corticosteroids for treatment; Short term use of corticosteroids for preventive treatment (such as preventing contrast agent allergies).
- Taking live attenuated vaccines within 4 weeks prior to the first dose of the study drug, or it is expected that live attenuated vaccines will be vaccinated during the study period.
- Participants who have previously received oncolytic virus therapy (such as T-vec, T3011, etc.), gene therapy, cell therapy, and tumor vaccines.
- Participants have a history of splenectomy or organ transplantation.
- Participants with the malignant tumors other than the disease treated in this study, except for the following:
- Malignant tumors that have undergone treatment with the aim of cure, at least more than 5 years from the drug treatment, have no known active diseases, and have a low potential risk of recurrence;
- Fully treated non-melanoma skin cancer or malignant freckle like nevi with no evidence of disease;
- In situ cancer with sufficient treatment and no evidence of disease.
- 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 gross hematuria.
- Indwelling ureteral stent or having a history of bladder ureteral reflux disease.
- Major cardiovascular diseases, such as New York Heart Association heart disease (grade II or higher), myocardial infarction within the first three months of enrollment, unstable arrhythmia or unstable angina.
- Having the history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wagner's granulomatosis, Sjogren's syndrome, Guillain Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Except for patients with hypothyroidism or diabetes who have good control of alternative treatment.
- Persistent or active infections exist, and drug treatment and control are still not ideal; Including but not limited to: active pulmonary tuberculosis, non negative AIDS virus (HIV) antibody, positive hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA) quantity ≥ the lower limit of the laboratory test in the research center, hepatitis C virus antibody (HCV Ab) positive and hepatitis C virus RNA quantity ≥ the lower limit of the laboratory test in the research center.
- Participants who require oral or intravenous use of anti herpesvirus drugs during the study period (including but not limited to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foxinkane, cedofovir, etc.) (excluding local use such as topical use).
- Participants with the history of allergic reactions to HSV-1, IL-12, or anti PD-1 antibodies and similar biological components, or those known to have allergic reactions to any component of T3011.
- Fever above 38.5 ℃ with no explained reason during the screening period, washout period/baseline period, or on the day of administration (the researcher determines that fever caused by tumors can be included), according to the researcher's judgment, may affect the patient's participation \in this trial or interfere with the evaluation of efficacy.
- In the period of recurrent herpes simplex virus infection, there are corresponding clinical manifestations, such as lip herpes, herpetic keratitis, herpetic dermatitis, genital herpes, etc.
- Participants who have previously developed non infectious pneumonia/interstitial pneumonia or are intolerant to immunotherapy drugs (including but not limited to anti PD-1/PD-L1 antibodies) (including but not limited to developing ≥ grade 3 immune related adverse events [irAEs]) (excluding endocrine related irAEs that can be stably controlled through hormone replacement therapy).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Dingwei Ye, Doctor, 021-64175590, dwyeli@163.com
About this study
Official title: A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Evaluate the Safety and Efficacy of T3011 in Patients With BCG-Failure Non-Muscle-Invasive Bladder Cancer (NMIBC)
This is a prospective, open-label, single-arm investigator-initiated clinical study. It is used to evaluate the safety and efficacy of T3011 intravesical instillation in patients with BCG-failure high-risk non-muscle invasive bladder cancer (NMIBC)
- Conditions
- Bladder Cancer
- Being tested
- Herpes virus T3011 injection
- Keywords
- high-risk non-muscle invasive bladder cancer (NMIBC), BCG failure or intolerance
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herpes virus T3011 injectionBiological
T3011 will be instilled in the entire solution volume of 50ml, and be will be left in the bladder for at least 1 hour, no more than 2 hours. After competing instillation, the patients should be instructed to drink at lest 1000mL of water
| Study group | Role | What they receive |
|---|---|---|
| Herpes virus T3011 injection | Experimental | T3011 with the dose of 5 x 10^7 PFU, 5 x 10^8 PFU or 2 x 10^9 PFU is administered via intravesical instillation, once a week (QW) for the first 12 weeks and then every 2 weeks (Q2W) until 12 months. Receives: Biological: Herpes virus T3011 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR rate or relapse-free survival rates at 3, 6, 9 and 12 months after the first study dose
Defined as the rate of Complete response or relapse-free survival at 3, 6, 9 and 12 months after first study drug administration
Measured: 3, 6, 9 and 12 months after first study dose
Recurrence-free survival, RFS
Defined as relapse-free survival time
Measured: Up to 2 years
Progression-free survival, PFS
Defined as time to progression-free survival
Measured: Up to 2 years
Incidence of radical cystectomy
Defined as the rate at which radical cystectomy occurs
Measured: Up to 2 years
5-year survival rate
Defined as survival rate at 5 year of administered treatment
Measured: Up to 5 years
Adverse Events, AE
Evaluation standard is CTCAE V5.0
Measured: up to 30 days after completion of treatment
Serious Adverse Event, SAE
Evaluation standard is CTCAE V5.0
Measured: up to 30 days after completion of treatment
Dose-limiting toxicity (DLT) events
Defined as a toxic reaction related to the test drug occurring within the first cycle of treatment, i.e. within 28 days of the first instillation
Measured: First cycle of treatment, i.e. within 28 days of first instillation
Abnormal clinically significant vital signs and their incidence
Abnormal clinically significant vital signs and their incidence
Measured: Up to 1 years
Abnormal clinically significant physical findings and their incidence
Abnormal clinically significant physical findings and their incidence
Measured: Up to 1 years
Abnormal clinically significant laboratory findings and their incidence
Abnormal clinically significant laboratory findings and their incidence
Measured: Up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start21 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding-Wei Ye, Fudan University
- Investigators
- Dingwei Ye, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427291
- Sponsor's protocol ID
- MVR-T3011-ES-EC61-UC
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Evaluate the Safety and Efficacy of T3011 in Patients With BCG-Failure Non-Muscle-Invasive Bladder Cancer (NMIBC)
- ClinicalTrials.gov ID
- NCT06427291
- Acronym / sponsor ID
- MVR-T3011-ES-EC61-UC
- Conditions
- Bladder Cancer
- Keywords
- high-risk non-muscle invasive bladder cancer (NMIBC), BCG failure or intolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 May 2024 (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 prospective, open-label, single-arm investigator-initiated clinical study. It is used to evaluate the safety and efficacy of T3011 intravesical instillation in patients with BCG-failure high-risk non-muscle invasive bladder cancer (NMIBC)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Herpes virus T3011 injection | Experimental | Biological: Herpes virus T3011 injectionT3011 with the dose of 5 x 10^7 PFU, 5 x 10^8 PFU or 2 x 10^9 PFU is administered via intravesical instillation, once a week (QW) for the first 12 weeks and then every 2 weeks (Q2W) until 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants who understand and voluntarily sign the written ICF, and are willing and able to comply with all trial requirements.
- Male or female, aged ≥ 18 years at the time of signing the ICF.
- Participants with a histologically confirmed diagnosis of NMIBC (Ta, T1 and/or Tis).
- Participants with high risk NMIBC who have been diagnosed by cystoscopy, urine cytology, and histopathology within 8 weeks prior to the first dose administration and have failed or intolerant to BCG treatment after TURBT surgery, and are not suitable or willing to undergo radical cystectomy.
- BCG-failure include BCG refractory, recurrence or relapsing after BCG treatment, BCG unresponsive and BCG intolerant.
Key exclusion criteria (24 listed)
- The diagnosis is confirmed as muscle invasive bladder cancer (T2-T4).
- Patients with concurrent upper and lower urinary tract epithelial carcinoma, lymph node metastasis, or distant metastasis.
- Pregnant and lactating female patients.
- Having major surgery within 4 weeks prior to the first dose of the study drug, or anticipate the need for major surgery rather than diagnosis after enrolling the study.
- In addition to immediate instillation therapy after TURBT surgery, anti-tumor drug treatments such as chemotherapy, radiation therapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc. have been received within 4 weeks prior to the first dose of the study drug (excluding nitroso urea, mitomycin C, oral fluorouracil, small molecule targeted drugs, and traditional Chinese medicine with anti-tumor indications). Nitrso urea or mitomycin C is within 6 weeks prior to the first use of the study drug, and oral fluorouracil and small molecule targeted drugs are within 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug (whichever is longer). Traditional Chinese medicine with anti-tumor indications is within 2 weeks prior to the first dose of the study drug.
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 |
|---|---|---|
| Herpes virus T3011 injectionT3011 will be instilled in the entire solution volume of 50ml, and be will be left in the bladder for at least 1 hour, no more than 2 hours. After competing instillation, the patients should be instructed to drink at lest 1000mL of water | Biological | Herpes virus T3011 injection |
Primary outcome
CR rate or relapse-free survival rates at 3, 6, 9 and 12 months after the first study dose
Time frame: 3, 6, 9 and 12 months after first study dose
Defined as the rate of Complete response or relapse-free survival at 3, 6, 9 and 12 months after first study drug administration
Recurrence-free survival, RFS
Time frame: Up to 2 years
Defined as relapse-free survival time
Progression-free survival, PFS
Time frame: Up to 2 years
Defined as time to progression-free survival
Incidence of radical cystectomy
Time frame: Up to 2 years
Defined as the rate at which radical cystectomy occurs
5-year survival rate
Time frame: Up to 5 years
Defined as survival rate at 5 year of administered treatment
Adverse Events, AE
Time frame: up to 30 days after completion of treatment
Evaluation standard is CTCAE V5.0
Serious Adverse Event, SAE
Time frame: up to 30 days after completion of treatment
Evaluation standard is CTCAE V5.0
Dose-limiting toxicity (DLT) events
Time frame: First cycle of treatment, i.e. within 28 days of first instillation
Defined as a toxic reaction related to the test drug occurring within the first cycle of treatment, i.e. within 28 days of the first instillation
Abnormal clinically significant vital signs and their incidence
Time frame: Up to 1 years
Abnormal clinically significant vital signs and their incidence
Abnormal clinically significant physical findings and their incidence
Time frame: Up to 1 years
Abnormal clinically significant physical findings and their incidence
Abnormal clinically significant laboratory findings and their incidence
Time frame: Up to 1 years
Abnormal clinically significant laboratory findings and their incidence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dingwei Ye, Doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Herpes virus T3011 injection in people with Bladder Cancer, run by Fudan University at 1 site in China.
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 14 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dingwei Ye, Doctor (021-64175590, dwyeli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR rate or relapse-free survival rates at 3, 6, 9 and 12 months after the first study dose (time frame: 3, 6, 9 and 12 months after first study dose). The study lists 11 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 23 May 2024.