Actively Recruiting
A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy
Led by Ractigen Therapeutics. · Updated on 2025-09-11
72
Participants Needed
3
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the study and provide informed consent
- Adults aged 18 years or older
- Pathologically confirmed high-grade non-muscle-invasive bladder cancer (grade 2 or grade 3)
- Expected survival of at least 6 months
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2
- Adequate organ function including hematology, liver, and kidney function as defined by specific lab values
- Ability to tolerate bladder catheterization
- Female participants of childbearing potential and their partners must use effective non-pharmacological contraception from consent until 6 months after last treatment
You will not qualify if you...
- Allergy to RAG-01 or similar products
- Received anti-tumor treatments other than TURBT within 21 days or 5 half-lives before consent
- Presence of extravesical metastasis including ureter and urethra
- Other malignancies within the past 3 years except certain treated cancers
- Uncontrolled infections such as pneumonia or hepatitis B/C
- Dyspnea not relieved to mild severity
- Acute or chronic kidney injury or inflammation
- Urinary incontinence or urinary frequency
- Urinary tract obstruction except benign prostatic hypertrophy
- Inability to hold urine for at least 90 minutes
- New York Heart Association class 3 or 4 heart failure
- Unrelieved coronary heart disease symptoms including myocardial infarction and arrhythmia
- QTc interval greater than 470 milliseconds
- Unrelieved cerebrovascular accidents
- HIV positive or active hepatitis B or C
- Pregnancy or breastfeeding during treatment
- History of central nervous system or psychiatric disorders such as epilepsy or dementia
- Other severe systemic diseases compromising study compliance
- Any condition judged by investigators to pose unnecessary risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
GenesisCare North Shore
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
2
The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Actively Recruiting
3
Peninsula & South Eastern Haematology and Oncology Group
Melbourne, Victoria, Australia, 3199
Actively Recruiting
Research Team
L
Long-Cheng Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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