Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

Cohort A Key Inclusion Criteria:

• Pathologically confirmed BCG-naïve high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
• All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
• Acceptable baseline organ function.

Cohort B Key Inclusion Criteria:

• Pathologically confirmed BCG-exposed high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
• All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
• Acceptable baseline organ function.

Cohort CX Inclusion Criteria

• Pathologically confirmed high-risk high-grade BCG-unresponsive or BCG-exposed NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
• All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
• Acceptable baseline organ function.

Key Exclusion Criteria (Both Cohorts):

• Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer.
• High-grade urothelial carcinoma in the upper urinary tract or prostatic urethra within 24 months or T2 in upper tract within 48 months or any history of locally advanced/ nodal or metastatic disease in the upper urinary tract.
• Significant immunodeficiency.
• Pregnant or breastfeeding.
• Cohort CX Only: serial intravesical gemcitabine within 24 months