ImmVira Pharma Co. Ltd
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.
In Cohort A, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (CIS with or without Ta or T1 papillary) which is unresponsive to BCG treatment. In Cohort B, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (Ta/T1 papillary without CIS) which is unresponsive to BCG treatment. In Cohort C, participants will be enrolled with pathologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (CIS with or without Ta or T1 papillary) which has previously been ex…
Inclusion Criteria: Participants may enter the study only if they meet all the following criteria: 1. Male or female, aged ≥18 years at the time of signing the ICF. 2. The participants will need to meet the following criteria: 1. Participants with a histologically confirmed diagnosis of NMIBC (Ta, T1 and/or Cis). 2. During the study, the participants must voluntarily comply with the study-specified cystoscopy, urine cytology and randomized biopsy. 3. All toxicities caused by prior radiotherapy, chemotherapy or other treatments have recovered to Grade ≤1 (CTCAE 5.0) (except for alopeci…
T3011 will be administered at a dose of 1x10\^10 PFU intravesically.