Tests RAG-01 in bladder cancer that returned after BCG treatment

Trial details

Who runs it

Ractigen Therapeutics.

Trial code

NCT06351904

Record updated

11 September 2025

Original description

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.Read full original descriptionShow less

A Phase Ⅰ, Open Label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy

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.

Inclusion: Ability to understand the study and have signed the informed consent form; Any adult ≥ 18 years old; 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.

Exclusion: 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; Subject has other malignancies within the past 3 years, except for adequately treated carcinoma of the cervix, basal or squamous cell carcinomas of the skin, or adenocarcinoma of the prostate that has been surgically treated with a post-treatment PSA that is non-detectable; Subject who is allergy to RAG-01 or similar products; The following illnesses have not been relieved to CTCAE 0-1:; Uncontrolled acute and chronic infections, such as pneumonia, biliary tract infection, hepatitis B virus infection and hepatitis C virus infection; Dyspnea; Acute and chronic kidney injury, and inflammation; Urinary incontinence; Urinary frequency; Urinary tract obstruction (except benign prostatic hypertrophy); New York Heart Association (NYHA) 3 or 4 grade; Coronary heart disease related symptoms have not been relieved to CTCAE 0-1, including: myocardial infarction, unstable angina pectoris, congestive heart failure and arrhythmia; History of central nervous system or psychiatric disorders, e.g., epilepsy or dementia; Other severe systemic diseases which might compromise the subject's compliance to the study, e.g., uncontrolled diabetes, gastrointestinal disorders, and renal diseases; Subject with QTc >470 msec; HIV positive; Active hepatitis B or C. For active HBV, it's defined as HBsAg positive with HBV DNA ≥ ULN, for active HCV, it's defined as HCV antibody positive with HCV RNA ≥ ULN, respectively; Subject with imaging examination diagnosed extravesical metastasis, including ureter and urethra; Subject could not hold the urine for at least 90 mins due to any reason; Cerebrovascular accidents have not been relieved to CTCAE 0-1; Subject is pregnant or lactating during the treatment period; Any other situations which are judged by the investigator, would exposure the subject to unnecessary risk, therefore he/she is not eligible.

ClinicalTrials.gov NCT06351904