A Phase 2 interventional study of RAG-01 and Chemotherapy agent in Non-muscle Invasive Bladder Cancer (NMIBC), sponsored by Ractigen Therapeutics.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Ractigen Therapeutics. · Phase 2, Interventional, and Treatment
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Among 50 studies in Non-Muscle Invasive Bladder Neoplasms with a site in China — 40 open to participants now, 44 under way, 10 of them phase 3. Non-Muscle Invasive Bladder Neoplasms · China.
Among the 50 studies in Non-Muscle Invasive Bladder Neoplasms with a site in China, this one is the 24th largest by planned enrollment of the 47 interventional ones that give a count, is one of 10 that started in 2026, is one of 13 in phase 2, reaches primary completion later than 35 of the 43 other live ones, and was the 49th registered.
294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.
Browse Non-Muscle Invasive Bladder Neoplasms studies →40 of the 50 studies in Non-Muscle Invasive Bladder Neoplasms with a site in China are open now. Recruiting first, the newest first:
Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Sites in China
Ages 18+
Tianjin Medical University Second Hospital · Sites in China
Ages 18+
Jiangsu Hansoh Pharmaceutical Co., Ltd. · Sites in China
Ages 18+
Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Sites in China
Ages 18+
Tianjin Medical University Second Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 92 Non-Muscle Invasive Bladder Neoplasms studies recruiting now, 77 (84%) set no upper age limit and 5 (5%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
50 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 21 · Phase 3 12 · Phase 4 1
First in 2017; this study’s year is marked. 10 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 114 is above the median of 62 across 231 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Median enrollment 114 across the 47 interventional studies, 300 across the 3 observational. Of the 3 that completed or were terminated, 2 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
23 of 50 have an industry lead sponsor. The 10 most frequent:
Ractigen Therapeutics. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Ractigen Therapeutics. has 2 studies filed under Non-Muscle Invasive Bladder Neoplasms — fewer than ten, so there is no comparison to draw.
12 of the studies in Non-Muscle Invasive Bladder Neoplasms with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06696794Phase 3Shaogang WangInvestigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients | 2027-06-30 |
| NCT07252297Xijing HospitalThe Role of Universal Cancer Only Marker SIX6 in Diagnosing Non-Muscle Invasive Bladder Cancer | 2026-12-30 |
| NCT06108492Shanghai Hengrui Pharmaceutical Co., Ltd.A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC) | 2026-12-31 |
| NCT06186414Jiangsu Simcere Pharmaceutical Co., Ltd.A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC | 2027-01 |
| NCT07483970Jecho Biopharmaceuticals Co., Ltd.A Phase I/II Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer. | 2027-03-30 |
Add all 12 to your calendar (.ics) → With an account.
Among the 50 studies in Non-Muscle Invasive Bladder Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a randomized, controlled, multicenter clinical study to evaluate the efficacy and safety of RAG-01 monotherapy and in combination with chemotherapy in patients with NMIBC.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Has confirmed tumor tissue obtained within 12 weeks prior to the first study treatment, with urothelial carcinoma as the predominant histologic subtype (≥90%), and is classified according to the American Urological Association (AUA) guidelines as follows:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High-risk NMIBC patients will be enrolled in a safety lead-in phase to evaluate the safety, tolerability, and initial efficacy of RAG-01 as monotherapy and in combination with a chemotherapy agent, and to determine the recommended dose. Approximately 12-24 patients will be enrolled in this lead-in phase, and these patients will receive non-randomized treatment. Following completion of the safety assessment during the safety lead-in phase and confirmation of acceptable safety results, additional eligible patients will be enrolled into a randomized controlled phase. In the randomized phase, patients will be randomized 1:1 to either RAG-01 monotherapy or RAG-01 plus a chemotherapy agent.
Drug: RAG-01 · Drug: Chemotherapy agent
Intermediate-risk NMIBC patients will receive RAG-01 monotherapy.
Drug: RAG-01
RAG-01 is a therapeutic small activating RNA (saRNA) duplex molecule comprised of two partially chemically modified complementary oligonucleotide strands.
Chemotherapy agent administered in combination with RAG-01.
Efficacy of RAG-01 in patients with non-muscle-invasive bladder cancer (NMIBC)
Event-Free Survival rate
Time frame: 24 months
Start is estimated for Sep 2026; primary completion for Mar 2029, 30 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Non-Muscle Invasive Bladder Neoplasms →
Ractigen Therapeutics.