Brief Summary
This is an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy.
Intervention / Treatment
- Drug: RAG-01
Inclusion Criteria:
- Ability to understand the study and have signed the informed consent form;
- ≥ 18, ≤ 75 years old, male or female;
- Pathologically confirmed high grade NMIBC defined as grade 2 or grade 3 disease;
- Expected survival ≥ 6 months;
- ECOG PS ≤2;
- Sufficient organ functions, as defined below:Investigations Hematology Absolute Neutrophil Count (ANC): ≥ 1.5 x 109/L Hemoglobin: ≥ 90 g/L Platelet: ≥ 100 x 109/L Liver Function Serum bilirubin: ≤ 1.25×ULN or 2.5×ULN（with Gilbert syndrome） AST & ALT: ≤ 2.5×ULN Renal Function Creatinine Clearance (Cockcroft-Gault equation): ≥ 30 mL/min
- Subject must be able to tolerate catheterization;
- Female subject of childbearing potential and her spouse must use adopt effective contraception (non-pharmacological contraception required) from signing informed consent to within 6 months after the last instillation.