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.
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 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.
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.
Single group
T3011
Biological/VaccineT3011 will be administered at a dose of 1x10\^10 PFU intravesically.
Complete Response Rate in patients with CIS
Recurrence Free Survival Rate in patients with Ta/T1 (without CIS)
Incidence rates of Grade ≥3 treatment-related adverse events (TRAEs)
Incidence rates of TRAEs leading to treatment discontinuation, dose modification or treatment interruption.
Complete Response Rate in patients with CIS
Recurrence Free Survival Rate in patients with Ta/T1 (without CIS)
Safety Endpoints
* Incidence rates of Grade ≥3 treatment-emergent adverse events (TEAEs) * Incidence rates of all grades of TRAEs * Incidence rates of AEs leading to treatment discontinuation, dose modification or treatment interruption
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