Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC Patients

Must have received: BCG therapy — after TURBT surgery

failed or intolerant to BCG treatment after TURBT surgery

Cannot have received: oncolytic virus therapy (T-vec, T3011)

previously received oncolytic virus therapy (such as T-vec, T3011, etc.)

Cannot have received: gene therapy

previously received ... gene therapy

Cannot have received: cell therapy

previously received ... cell therapy

Cannot have received: tumor vaccines

previously received ... tumor vaccines

Cannot have received: systemic corticosteroids (prednisone)

Exception: excluding local, ocular, intra-articular, intranasal, and inhaled corticosteroids; short term use for preventive treatment

systemic corticosteroids (prednisone>10mg/day or equivalent) or other immunosuppressive treatments within 14 days prior to the first dose

Cannot have received: anti-tumor drug treatments (chemotherapy, radiation therapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy)

Exception: excluding immediate instillation therapy after TURBT surgery, nitroso urea, mitomycin C, oral fluorouracil, small molecule targeted drugs, and traditional Chinese medicine with anti-tumor indications (see timing restrictions)

anti-tumor drug treatments ... within 4 weeks prior to the first dose ... (excluding nitroso urea, mitomycin C, oral fluorouracil, small molecule targeted drugs, and traditional Chinese medicine with anti-tumor indications). Nitroso urea or mitomycin C is within 6 weeks ... oral fluorouracil and small molecule targeted drugs are within 2 weeks ... or within 5 half-lives ... Traditional Chinese medicine ... within 2 weeks