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New virus therapy takes on tough bladder cancer

NCT ID NCT07283835

Disease control Sponsor: Lepu Biopharma Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a treatment called cretostimogene grenadenorepvec, a modified virus designed to infect and destroy cancer cells, in 16 people with high-risk bladder cancer that has not responded to standard BCG therapy. The study aims to see if the treatment can make tumors disappear and how long that effect lasts. Participants receive the virus directly into the bladder, along with a helper substance to improve its action.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cretostimogene grenadenorepvec (a modified virus that targets and kills cancer cells)
What this could lead to
If it works, this could offer a new treatment option for people with bladder cancer that has not responded to standard therapy, potentially delaying or avoiding the need for bladder removal.
What could go wrong
This is a small, early-phase trial with only 16 participants, so results may not apply to everyone. The treatment may cause side effects or fail to control the cancer long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: In order to be eligible for participation in this trial, the patient must: 1. 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. 2. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 3. Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment. 4. Demonstrate adequate organ function. 5. 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. 6. Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment. Exclusion Criteria: 1. Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer. 2. 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. 3. Has received systemic anti-cancer therapy, including investigational agents. 4. 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. 5. 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. 6. Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.

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Conditions

The condition(s) this trial relates to.

bladder carcinoma in situ bladder papillary urothelial carcinoma in situ carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

High-grade ta/ T1 papillary disease bladder cancer Non-muscle invasive bladder cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    14 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Chongqing University Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400030, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410013, China

  • Peking University First Hospital (First Clinical Medical School of Peking University)

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250012, China

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • The Affiliated Drum Tower Hospital of Nanjing University Medical School

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110001, China

  • The Second Hospital of Tianjin Medical University

    RECRUITING

    Tianjin, Tianjin Municipality, 300211, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430022, China

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

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