Non Muscle Invasive Bladder CancerPhase 2NCT07283835
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
A Phase 2 study testing Cretostimogene Grenadenorepvec and n-dodecyl-B-D-maltoside in people with Non Muscle Invasive Bladder Cancer and High-grade Ta/ T1 Papillary Disease Bladder Cancer, run by Lepu Biopharma Co., Ltd. at 14 sites in China.
Trial summary
This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer
- What is being tested?
- Cretostimogene Grenadenorepvec and n-dodecyl-B-D-maltoside
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 14 sitesChina
- Study dates
- 4 Dec 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible for participation in this trial, the patient must:
- Be ≥18 years of age on day of signing informed consent.
- Patients must have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without concomitant Ta/T1 papillary disease.
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment.
- Demonstrate adequate organ function.
- Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial.
- Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment.
Who cannot join
- Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer.
- History of urothelial carcinoma in the upper genitourinary tract (kidney, renal collecting system, ureter) or in the prostatic urethra, including urethral CIS, within 24 months prior to enrollment.
- Has received systemic anti-cancer therapy, including investigational agents.
- Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies.
- Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure.
- Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Peking University First Hospital (First Clinical Medical School of Peking University)
Beijing, Beijing Municipality, 100034
Zhisong He, 86-13141316696, wyj7074@sohu.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Shusuan Jiang, 86-731-88651269, lkunyan@163.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Zhang Peng, 86-28-85423655, lzheng2005618@aliyun.com
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Fang Yuan, 86-23-65456552, 775059475@qq.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Yu Chen, 86-591-62752500, fjszlyyjgb@163.com
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Baiye Jin, 86-13958027659, inbaive1964@ziu.edu.cn
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Benkang Shi, 86-531-82165412, qlyygcp_ms@qiluhospital.com
- Recruiting
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Hongqian Guo, 86-25-83105910, dr.ghq@163.com
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Danfeng Xu, 86-21-63085543, xdf12036@rjh.com.cn
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dinɡwei Ye, M.D., 86-21-64175590, fuscc2012@163.com
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Jianbin Bi, 86-24-83283392, zhouliping750825@163.com
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Hailong Hu, 86-13920223774, huhailong@tmu.edu.cn
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Hang Huang, 86-13857727395, fuscc2012@163.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Xiaoping Zhang, 86-27-85726685, whuniongcp@126.com
About this study
Official title: A Single-arm, Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Cretostimogene Grenadenorepvec in Patients With BCG-unresponsive High-risk Non-Muscle Invasive Bladder Cancer
This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.
Read the detailed description
An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease.
- Being tested
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Keywords
- high-grade Ta papillary disease, high-grade T1 papillary disease, carcinoma in situ, Bacillus-Calmette-Guerin unresponsive
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cretostimogene GrenadenorepvecBiological
Also called CG0070
Engineered Oncolytic Adenovirus
n-dodecyl-B-D-maltosideOther
Also called DDM
Transduction-enhancing agent
| Study group | Role | What they receive |
|---|---|---|
| Cretostimogene | Experimental | Patients with CIS with or without HG Ta/T1 papillary disease. Cretostimogene will be administered intravesically following a series of bladder washes with 5% DDM and normal saline. Cretostimogene will be administered weekly for specific schedule per protocol. Receives: Biological: Cretostimogene Grenadenorepvec; Other: n-dodecyl-B-D-maltoside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS
Measured: 36 months
Secondary outcomes (6)
Duration of response (DOR)
Time from first documented objective response to disease progression or death from any cause.
Measured: 36 months
Assess high-grade reoccurrence free survival (RFS)
Time from first treatment to first recurrence of high-grade disease or death from any cause.
Measured: 36 months
Assess progression free survival (PFS)
Time from first treatment to tumor progression or death from any cause.
Measured: 36 months
Complete response rate at 12, 24, and 36 months
Proportion of patients achieving complete response at 12, 24, and 36 months.
Measured: Assessed at 12, 24, and 36 months
Overall survival rate at 36 months
Proportion of patients alive at 36 months.
Measured: 36 months
Safety: incidence and severity of adverse events (AE) and serious adverse events (SAE)
Safety is evaluated based on NCI-CTCAE v5.0 criteria. This includes incidence and severity of all adverse events (AE), serious adverse events (SAE), and abnormal laboratory values.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start4 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Lepu Biopharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lepu Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dinɡwei Ye, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283835
- Sponsor's protocol ID
- CG0070-II-CIS-01
- Status last verified
- Jan 2026
- First submitted
- 6 Dec 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Cretostimogene Grenadenorepvec in Patients With BCG-unresponsive High-risk Non-Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07283835
- Acronym / sponsor ID
- CG0070-II-CIS-01
- Keywords
- high-grade Ta papillary disease, high-grade T1 papillary disease, carcinoma in situ, Bacillus-Calmette-Guerin unresponsive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Lepu Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.
Detailed description
An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cretostimogene | Experimental | Biological: Cretostimogene Grenadenorepvec, Other: n-dodecyl-B-D-maltosidePatients with CIS with or without HG Ta/T1 papillary disease. Cretostimogene will be administered intravesically following a series of bladder washes with 5% DDM and normal saline. Cretostimogene will be administered weekly for specific schedule per protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be ≥18 years of age on day of signing informed consent.
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment.
- Demonstrate adequate organ function.
- Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial.
Key exclusion criteria (6 listed)
- Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer.
- History of urothelial carcinoma in the upper genitourinary tract (kidney, renal collecting system, ureter) or in the prostatic urethra, including urethral CIS, within 24 months prior to enrollment.
- Has received systemic anti-cancer therapy, including investigational agents.
- Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies.
- Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cretostimogene GrenadenorepvecAlso: CG0070Engineered Oncolytic Adenovirus | Biological | Cretostimogene |
| n-dodecyl-B-D-maltosideAlso: DDMTransduction-enhancing agent | Other | Cretostimogene |
Primary outcome
Complete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS
Time frame: 36 months
6 secondary outcomes
Duration of response (DOR)
Time frame: 36 months
Assess high-grade reoccurrence free survival (RFS)
Time frame: 36 months
Assess progression free survival (PFS)
Time frame: 36 months
Complete response rate at 12, 24, and 36 months
Time frame: Assessed at 12, 24, and 36 months
Overall survival rate at 36 months
Time frame: 36 months
Safety: incidence and severity of adverse events (AE) and serious adverse events (SAE)
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dinɡwei Ye, M.D. principal investigator
Fudan University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cretostimogene Grenadenorepvec and n-dodecyl-B-D-maltoside in people with Non Muscle Invasive Bladder Cancer and High-grade Ta/ T1 Papillary Disease Bladder Cancer, run by Lepu Biopharma Co., Ltd. at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Program Director (86-21-61637960, clinicaltrials@lepubiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.