NCT06351904 A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy
| NCT ID | NCT06351904 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ractigen Therapeutics. |
| Condition | Non-Muscle-Invasive Bladder Cancer (NMIBC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2024-04-03 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 72 participants in total. It began in 2024-04-03 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Ability to understand the study and have signed the informed consent form; 2. Any adult ≥ 18 years old; 3. Pathologically confirmed high grade NMIBC defined as grade 2 or grade 3 disease; 4. Expected survival ≥ 6 months; 5. ECOG PS ≤2; 6. 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 7. Subject must be able to tolerate catheterization; 8. 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 Criteria: 1. Subject who is allergy to RAG-01 or similar products; 2. 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; 3. Subject with imaging examination diagnosed extravesical metastasis, including ureter and urethra; 4. 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; 5. The following illnesses have not been relieved to CTCAE 0-1: 1. Uncontrolled acute and chronic infections, such as pneumonia, biliary tract infection, hepatitis B virus infection and hepatitis C virus infection; 2. Dyspnea; 3. Acute and chronic kidney injury, and inflammation; 4. Urinary incontinence; 5. Urinary frequency; 6. Urinary tract obstruction (except benign prostatic hypertrophy); 6. Subject could not hold the urine for at least 90 mins due to any reason; 7. New York Heart Association (NYHA) 3 or 4 grade; 8. Coronary heart disease related symptoms have not been relieved to CTCAE 0-1, including: myocardial infarction, unstable angina pectoris, congestive heart failure and arrhythmia; 9. Subject with QTc \>470 msec. 10. Cerebrovascular accidents have not been relieved to CTCAE 0-1; 11. 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. 12. Subject is pregnant or lactating during the treatment period; 13. History of central nervous system or psychiatric disorders, e.g., epilepsy or dementia; 14. Other severe systemic diseases which might compromise the subject's compliance to the study, e.g., uncontrolled diabetes, gastrointestinal disorders, and renal diseases; 15. Any other situations which are judged by the investigator, would exposure the subject to unnecessary risk, therefore he/she is not eligible.
Contact & Investigator
Laurence Krieger, MBCHB
PRINCIPAL INVESTIGATOR
GenesisCare, 7 Westbourne Street, St Leonards, NSW 2065, Australia
Frequently Asked Questions
Who can join the NCT06351904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-Muscle-Invasive Bladder Cancer (NMIBC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06351904 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06351904 currently recruiting?
Yes, NCT06351904 is actively recruiting participants. Contact the research team at lilc@ractigen.com for enrollment information.
Where is the NCT06351904 trial being conducted?
This trial is being conducted at St Leonards, Australia, Melbourne, Australia, Melbourne, Australia.
Who is sponsoring the NCT06351904 clinical trial?
NCT06351904 is sponsored by Ractigen Therapeutics.. The principal investigator is Laurence Krieger, MBCHB at GenesisCare, 7 Westbourne Street, St Leonards, NSW 2065, Australia. The trial plans to enroll 72 participants.
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