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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06351904 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-tumor treatments (except TURBT) disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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 qualifyRelated pages