An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG

September 9, 2026 updated by: CG Oncology, Inc.

An Expanded Access Program of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All participants will be assigned the same treatment schedule. Participants will receive an induction course of 6 weekly treatments, and, if there is no disease recurrence at Week 13, participants will receive a cycle of 3 weekly treatments up to Week 15.

If there is persistent HG Ta and/or CIS at Week 13, participants may receive a second induction cycle.

If the participant has persistent but improved HG Ta and/or CIS at Week 25 or a later timepoint, the participant may receive a cycle of 3 weekly treatments of cretostimogene at the discretion of the Investigator provided that T1 or higher stage of urothelial carcinoma is not present.

If there is no disease present at Week 25 or a later timepoint, participants will receive a cycle of 3 weekly treatments every 12 weeks through Month 12.

After Month 12, participants will receive a cycle of 3 weekly treatments every 6 months through the last treatment cycle at Month 24, or until discontinuation from the study treatment.

Disease status will be assessed based on local standard of care (which may include urine cytology, cystoscopy, and directed TURBT/biopsy) every 12 weeks. CTU/MRU can be done per standard of care evaluation at investigator's discretion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Available
        • Banner MD Anderson Cancer Center
    • California
      • Bakersfield, California, United States, 93301
        • Available
        • Michael G. Oefelein Clinical Trials
      • Los Angeles, California, United States, 90033
        • Available
        • University of Southern California / Norris Comprehensive Cancer Center
      • Murrieta, California, United States, 92563
        • Available
        • McR, Llc.
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Available
        • MedStar Washington Hospital Center
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Available
        • Advanced Urology Institute
      • Lakeland, Florida, United States, 33805
        • Available
        • Lakeland Regional Medical Center - Hollis Cancer Center
      • Largo, Florida, United States, 33771
        • Available
        • Advanced Urology Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Available
        • Emory University
    • Illinois
      • Chicago Ridge, Illinois, United States, 60415
        • Available
        • Uropartners c/o Associated Urological Specialists
      • Glenview, Illinois, United States, 60026
        • Available
        • UroPartners, LLC
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Available
        • Urologic Specialists of Northwest Indiana
    • Iowa
      • Clive, Iowa, United States, 50325
        • Available
        • Urology Center of Iowa Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Available
        • Brigham and Women's Hospital
    • Michigan
      • Troy, Michigan, United States, 40484
        • Available
        • Michigan Institute of Urology, PC
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Available
        • Mayo Clinic Rochester
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Available
        • The Urology Group, P.C.
    • Nevada
      • Reno, Nevada, United States, 89511
        • Available
        • Urology Nevada
    • New York
      • New York, New York, United States, 10016
        • Available
        • Integrated Medical Professionals, PLLC
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Available
        • MidLantic Urology
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Available
        • Lowcountry Urology Clinics, PA
    • Texas
      • Arlington, Texas, United States, 76017
        • Available
        • Urology Partners of North Texas Research Institute
      • Dallas, Texas, United States, 75231
        • Available
        • Urology Clinics of North Texas
      • San Antonio, Texas, United States, 78229
        • Available
        • Urology San Antonio, PA dba USA Clinical Trials
      • Wichita Falls, Texas, United States, 76301
        • Available
        • Digestive Health Research of North Texas
    • Washington
      • Seattle, Washington, United States, 98195
        • Available
        • University of Washington Medical Center
      • Spokane, Washington, United States, 99202
        • Available
        • Spokane Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CG Oncology, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRETO-EAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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