Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Cohort A Key Inclusion Criteria:
• Pathologically confirmed BCG-naïve high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
• All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
• Acceptable baseline organ function.
• Cohort B Key Inclusion Criteria:
• Pathologically confirmed BCG-exposed high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
• All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
• Acceptable baseline organ function.
• Cohort CX Inclusion Criteria
• Pathologically confirmed high-risk high-grade BCG-unresponsive or BCG-exposed NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.
• All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.
• Acceptable baseline organ function.
• Key Exclusion Criteria (Both Cohorts):
• Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer.
• High-grade urothelial carcinoma in the upper urinary tract or prostatic urethra within 24 months or T2 in upper tract within 48 months or any history of locally advanced/ nodal or metastatic disease in the upper urinary tract.
• Significant immunodeficiency.
• Pregnant or breastfeeding.
• Cohort CX Only: serial intravesical gemcitabine within 24 months

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

cretostimogene grenadenorepvec. A recombinant oncolytic adenovirus encoding the immunohematopoietic cytokine granulocyte-macrophage colony stimulating factor (GM-CSF) with potential antineoplastic activity. Upon administration, cretostimogene grenadenorepvec selectively infects and replicates in tumor cells, which may result in tumor cells lysis. Synergistically, GM-CSF expressed by the oncolytic adenovirus may promote a cytotoxic T cell response against tumor cells harboring the oncolytic adenovirus, resulting in an immune-mediated tumor cell death. NCI Drug Dictionary

Treatments listed in the registry

• Cretostimogene Grenadenorepvec (Drug): Respective Cohort

Randomized · Parallel · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• biopsy: Described as optional
• surgery: Described as optional

Main goals

• Cohort A (Arm 1 and 2): Complete response rate (At 11 and 24 weeks)
• Cohort A (Arm 3): High- Grade Event-Free Survival (48 months)
• Cohort B (Arm 1): Complete response rate (At 11 and 24 weeks)
• Cohort B (Arm 2): High-Grade Event-Free Survival (48 months)
• Cohort CX (Arms 1 and 2): High-Grade Event-Free Survival (48 months)
• Cohort CX (Arms 1 and 2): Safety (48 months)

Other goals

• Cohort A (Arms 1 and 2): Evaluate cretostimogene instillation methods
• Cohort A (Arm 3): High-Grade Event-Free Survival at 12 months
• Cohort A (Arms 1 and 2) and Cohort B (Arm 1) Duration of response
• Cohort B (Arm 2) High-Grade Event-Free Survival at 12 months
• Cohort CX (Arm 1 and 2) Complete response rate

Planned enrollment: 325 (estimated).

• Banner MD Anderson Cancer Center, Gilbert, Arizona
• Mayo Clinic Arizona, Phoenix, Arizona
• University of Arkansas for Medical Sciences, Little Rock, Arkansas
• Arkansas Urology, Little Rock, Arkansas
• Michael G Oefelein, MD Clinical Trials, Bakersfield, California
• City of Hope, Irvine, California
• Genesis Research (Greater Los Angeles), Los Alamitos, California
• Urology Center of Southern California, Murrieta, California
• University of California, Irvine, Orange, California
• UC Davis, Sacramento, California
• Om research, San Diego, California
• University of Southern California, San Diego, California
• Genesis Research (Greater Los Angeles), Torrance, California
• Colorado Urology, Lakewood, Colorado
• Urology Associates, Lone Tree, Lone Tree, Colorado
• University of Florida, Gainesville, Florida
• Mayo Clinic Florida, Jacksonville, Florida
• Advanced Urology Institute (Solaris), Largo, Florida
• Advanced Urology Institute, Oxford, Florida
• Emory University, Atlanta, Georgia
• Associated Urological Specialists, Chicago Ridge, Illinois
• Uropartners, Glenview, Illinois
• Accellacare, Lisle, Illinois
• Urology of Indiana - Carmel, Carmel, Indiana
• Urology of Indiana, LLC (US Urology Partners), Greenwood, Indiana
• First Urology, PSC, Jeffersonville, Indiana
• Urologic Specialists of Northwest Indiana (Solaris), Merrillville, Indiana
• Urology Center of Iowa Research, Clive, Iowa
• Wichita Urology Group, Wichita, Kansas
• Southern Urology (Urology America), Lafayette, Louisiana
• Ochsner Medical Center, New Orleans, Louisiana
• Anne Arundel Urology, Annapolis, Maryland
• Chesapeake Urology Research Associates, Hanover, Maryland
• Brigham and Women's Hospital, Boston, Massachusetts
• Comprehensive Urology, Royal Oak, Michigan
• Michigan Institute of Urology (Solaris), Troy, Michigan
• Mayo Clinic Rochester, Rochester, Minnesota
• Minnesota Urology, Woodbury, Minnesota
• Specialty Clinical Research of St. Louis, St Louis, Missouri
• Adult and Adolescent Urology, Omaha, Nebraska
• Hackensack University Medical Center, Hackensack, New Jersey
• Integrated Medical Professionals, PLLC (Solaris), New York, New York
• University of Rochester, Rochester, New York
• SUNY Upstate, Syracuse, New York
• Associated Medical Professionals of NY, PLLC (US Urology Partners), Syracuse, New York
• Montefiore Medical Center, The Bronx, New York
• University of North Carolina, Chapel Hill, North Carolina
• Atrium Health/Levine Center, Charlotte, North Carolina
• Associated Urologist of North Carolina (Solaris), Raleigh, North Carolina
• The Urology Group (Solaris), Cincinnati, Ohio
• University of Cincinnati Cancer Center, Cincinnati, Ohio
• Cleveland Clinic, Cleveland, Ohio
• Ohio State University, Columbus, Ohio
• Central Ohio Urology Group (US Urology Partners), Gahanna, Ohio
• Oregon Health & Science University, Portland, Oregon
• Portland VA, Portland, Oregon
• Oregon Urology Institute, Springfield, Oregon
• Midlantic Urology (Solaris), Bala-Cynwyd, Pennsylvania
• Penn State University Milton S. Hershey Medical Center, Hershey, Pennsylvania
• Keystone Urology Specialists, Lancaster, Pennsylvania
• University of Pennsylvania, Philadelphia, Pennsylvania
• Charleston Area Medical Center, Charleston, South Carolina
• Carolina Urologic Research Center, LLC, Myrtle Beach, South Carolina
• Lowcountry Urology (Solaris), North Charleston, South Carolina
• The Conrad Pearson Clinic (Urology America), Germantown, Tennessee
• Urology Associates, PC, Nashville, Tennessee
• UPNT Research Institute, LLC, Arlington, Texas
• Urology Austin, PLLC (Urology America), Austin, Texas
• Urology Clinics of North Texas, PLLC, Dallas, Texas
• UT Southwestern Medical Center, Dallas, Texas
• Houston Methodist, Houston, Texas
• Urology San Antonio, PA dba USA Clinical Trials, San Antonio, Texas
• Potomac Urology, Alexandria, Virginia
• Urology of Virginia, Virginia Beach, Virginia
• Spokane Urology, Spokane, Washington

1 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06567743
• NCI Drug Dictionary: C48412

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 2, 2026. Public record; not medical advice.