Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06427291

Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC Patients

Led by Fudan University · Updated on 2024-05-23

20

Participants Needed

1

Research Sites

118 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants who understand and voluntarily sign the informed consent form and can follow all trial requirements
  • Male or female aged 18 years or older at the time of consent
  • Histologically confirmed diagnosis of non-muscle invasive bladder cancer (Ta, T1 and/or Tis)
  • High-risk NMIBC diagnosed within 8 weeks before first dose, with BCG failure or intolerance after TURBT surgery, and not suitable or unwilling for radical cystectomy
  • BCG failure includes refractory, recurrence, unresponsive, or intolerant cases
  • No visible tumors after transurethral bladder tumor resection (TURBT); secondary resection recommended if criteria met, with no visible tumors after surgery
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Expected survival of at least 3 months
  • Adequate blood counts and organ function within 4 weeks before treatment, including ANC ≥1.5×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥90 g/L, creatinine clearance ≥60 mL/min, bilirubin ≤1.5× upper limit of normal, AST and ALT ≤3× upper limit of normal, INR or PT ≤1.5× upper limit of normal, aPTT ≤1.5× upper limit of normal
  • Women of childbearing potential must agree to use contraception during the study and for 6 months after, have a negative pregnancy test within 7 days before enrollment, and not be lactating
  • Men must agree to use contraception during the study and for 6 months after
Not Eligible

You will not qualify if you...

  • Diagnosis of muscle invasive bladder cancer (T2-T4)
  • Concurrent upper and lower urinary tract epithelial carcinoma, lymph node or distant metastasis
  • Pregnant or lactating women
  • Major surgery within 4 weeks before first dose or anticipated major surgery after enrollment
  • Anti-tumor treatments (chemotherapy, radiation, biological therapy, endocrine, targeted, immunotherapy) within 4 weeks before first dose, with specific exceptions and timing for certain drugs
  • Systemic corticosteroids or immunosuppressive treatments within 14 days before first dose, excluding certain local or short-term uses
  • Live attenuated vaccines within 4 weeks before first dose or planned during study
  • Previous oncolytic virus therapy, gene therapy, cell therapy, or tumor vaccines
  • History of splenectomy or organ transplantation
  • Other malignant tumors except fully treated cancers with low risk of recurrence
  • Unresolved toxicities from prior treatments above Grade 1 (except alopecia)
  • Indwelling ureteral stent or history of bladder ureteral reflux
  • Major cardiovascular diseases such as NYHA class II or higher heart disease, recent myocardial infarction, unstable arrhythmia or angina
  • History of autoimmune diseases except well-controlled hypothyroidism or diabetes
  • Active or persistent infections including tuberculosis, HIV, hepatitis B or C
  • Need for oral or intravenous anti-herpesvirus drugs during study
  • History of allergic reactions to HSV-1, IL-12, anti PD-1 antibodies, or components of T3011
  • Fever above 38.5°C without explanation during screening or dosing
  • Active recurrent herpes simplex virus infection
  • History of non-infectious or interstitial pneumonia or intolerance to immunotherapy drugs including anti PD-1/PD-L1 antibodies with severe immune related adverse events except stable endocrine irAEs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, China

Actively Recruiting

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Research Team

D

Dingwei Ye, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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