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)

Fudan University1 site in 1 country20 target enrollmentSeptember 21, 2023

ConditionsBladder Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Bladder Cancer
Sponsor: Fudan University
Enrollment: 20
Locations: 1
Primary Endpoint: Serious Adverse Event, SAE
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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)

Registry

clinicaltrials.gov

Start Date

September 21, 2023

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Ding-Wei Ye

Principal Investigator

Fudan University

Eligibility Criteria

Inclusion Criteria

•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.
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
•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.

Exclusion Criteria

•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.
•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.