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New Virus-Based therapy offered to bladder cancer patients who failed standard care

NCT ID NCT06443944

Disease control Sponsor: CG Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This program provides early access to cretostimogene grenadenorepvec, a virus-based therapy, for patients with non-muscle invasive bladder cancer that has not responded to standard BCG treatment. Eligible participants have a specific type of bladder cancer (CIS with or without high-grade Ta/T1). The goal is to offer a potential treatment option while gathering more information about its effects.

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 virus-based therapy that targets cancer cells)
What this could lead to
If successful, this could offer a new treatment option for patients with bladder cancer that hasn't responded to standard therapy, potentially delaying or avoiding bladder removal surgery.
What could go wrong
This is an expanded access program, not a formal trial, so data on effectiveness and safety are still limited. The therapy may not work for everyone and could have side effects.

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.

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

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: 1. Have pathologically confirmed BCG unresponsive CIS. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols. Specifically, the definition of BCG unresponsive CIS will also require the following: * Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease) * Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 15 months of the initial qualifying dose of BCG. 2. Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment 3. Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment. 4. Acceptable baseline organ function Exclusion Criteria: 1. Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer. 2. Has had active autoimmune or inflammatory disease requiring systemic treatment within 4 weeks of Day 1. Replacement therapy is not considered an excluded form of systemic treatment and is allowed. 3. Has received systemic anticancer therapy, including investigational agents, within 4 weeks of Day 1 4. Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 1 week after the last study treatment.

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Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm bladder carcinoma in situ malignant urinary system neoplasm non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms transitional cell carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

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

Bladder cancer Non-muscle invasive bladder cancer Urologic cancer Urothelial carcinoma

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

    27 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: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Advanced Urology Institute

    AVAILABLE

    Daytona Beach, Florida, 32114, United States

  • Advanced Urology Institute

    AVAILABLE

    Largo, Florida, 33771, United States

  • Banner MD Anderson Cancer Center

    AVAILABLE

    Gilbert, Arizona, 85234, United States

  • Brigham and Women's Hospital

    AVAILABLE

    Boston, Massachusetts, 02115, United States

  • Digestive Health Research of North Texas

    AVAILABLE

    Wichita Falls, Texas, 76301, United States

  • Emory University

    AVAILABLE

    Atlanta, Georgia, 30322, United States

  • Integrated Medical Professionals, PLLC

    AVAILABLE

    New York, New York, 10016, United States

  • Lakeland Regional Medical Center - Hollis Cancer Center

    AVAILABLE

    Lakeland, Florida, 33805, United States

  • Lowcountry Urology Clinics, PA

    AVAILABLE

    North Charleston, South Carolina, 29406, United States

  • Mayo Clinic Rochester

    AVAILABLE

    Rochester, Minnesota, 55905, United States

  • McR, Llc.

    AVAILABLE

    Murrieta, California, 92563, United States

  • MedStar Washington Hospital Center

    AVAILABLE

    Washington D.C., District of Columbia, 20010, United States

  • Michael G. Oefelein Clinical Trials

    AVAILABLE

    Bakersfield, California, 93301, United States

  • Michigan Institute of Urology, PC

    AVAILABLE

    Troy, Michigan, 40484, United States

  • MidLantic Urology

    AVAILABLE

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Spokane Urology

    AVAILABLE

    Spokane, Washington, 99202, United States

  • The Urology Group, P.C.

    AVAILABLE

    Southaven, Mississippi, 38671, United States

  • University of Southern California / Norris Comprehensive Cancer Center

    AVAILABLE

    Los Angeles, California, 90033, United States

  • University of Washington Medical Center

    AVAILABLE

    Seattle, Washington, 98195, United States

  • UroPartners, LLC

    AVAILABLE

    Glenview, Illinois, 60026, United States

  • Urologic Specialists of Northwest Indiana

    AVAILABLE

    Merrillville, Indiana, 46410, United States

  • Urology Center of Iowa Research

    AVAILABLE

    Clive, Iowa, 50325, United States

  • Urology Clinics of North Texas

    AVAILABLE

    Dallas, Texas, 75231, United States

  • Urology Nevada

    AVAILABLE

    Reno, Nevada, 89511, United States

  • Urology Partners of North Texas Research Institute

    AVAILABLE

    Arlington, Texas, 76017, United States

  • Urology San Antonio, PA dba USA Clinical Trials

    AVAILABLE

    San Antonio, Texas, 78229, United States

  • Uropartners c/o Associated Urological Specialists

    AVAILABLE

    Chicago Ridge, Illinois, 60415, United States

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