OncoMatch/Clinical Trials/NCT06351904
A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy
Is NCT06351904 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies RAG-01 for non-muscle-invasive bladder cancer (nmibc).
Treatment: RAG-01 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Excluded: Stage EXTRAVESICAL METASTASIS
Grade: grade 2grade 3
Pathologically confirmed high grade NMIBC defined as grade 2 or grade 3 disease; Subject with imaging examination diagnosed extravesical metastasis, including ureter and urethra [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: Bacillus Calmette Guérin therapy
Patients ... Who Have Failed Bacillus Calmette Guérin (BCG) Therapy
Cannot have received: anti-tumor treatments (except TURBT)
Exception: TURBT
Except for TURBT, the subject received other anti-tumor treatments, and the last administration date is within ≤ 21 days or 5 half-lifes whichever is shorter from the date of signing ICF
Lab requirements
Blood counts
Absolute Neutrophil Count (ANC): ≥ 1.5 x 10^9/L; Hemoglobin: ≥ 90 g/L; Platelet: ≥ 100 x 10^9/L
Kidney function
Creatinine Clearance (Cockcroft-Gault equation): ≥ 30 mL/min
Liver function
Serum bilirubin: ≤ 1.25×ULN or 2.5×ULN（with Gilbert syndrome）; AST & ALT: ≤ 2.5×ULN
Sufficient organ functions, as defined below: Hematology Absolute Neutrophil Count (ANC): ≥ 1.5 x 10^9/L Hemoglobin: ≥ 90 g/L Platelet: ≥ 100 x 10^9/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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify