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NCT06567743RecruitingPhase 2

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

A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Source: ClinicalTrials.gov · Last updated 3 Sept 2026

Brief summary (registry, in English)

This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
325 (estimated)
First submitted
14 Aug 2024
Start date
16 Sept 2024
Primary completion date
31 Mar 2027
Lead sponsor
CG Oncology, Inc.
NCT number
NCT06567743

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 325
  • From 16 Sept 2024 to the primary completion date, 31 Mar 2027
  • 80 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • Significant immunodeficiency.
  • Pregnant or breastfeeding.
  • Cohort CX Only: serial intravesical gemcitabine within 24 months

Criteria the registry did not label

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (80)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre of Applied Urology Research/Nova Scotia Health Authority
Coordinator of this site? Confirm its status
HalifaxCanadaRecruiting
Potomac Urology
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AlexandriaUnited StatesRecruiting
Amarillo Urology Research
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AmarilloUnited StatesCompleted
Anne Arundel Urology
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AnnapolisUnited StatesRecruiting
UPNT Research Institute, LLC
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ArlingtonUnited StatesRecruiting
Emory University
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AtlantaUnited StatesRecruiting
Urology Austin, PLLC (Urology America)
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AustinUnited StatesRecruiting
Michael G Oefelein, MD Clinical Trials
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BakersfieldUnited StatesRecruiting
Midlantic Urology (Solaris)
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Bala-CynwydUnited StatesRecruiting
Brigham and Women's Hospital
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BostonUnited StatesRecruiting
Urology of Indiana - Carmel
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CarmelUnited StatesRecruiting
University of North Carolina
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Chapel HillUnited StatesRecruiting
Charleston Area Medical Center
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CharlestonUnited StatesRecruiting
Atrium Health/Levine Center
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CharlotteUnited StatesRecruiting
Associated Urological Specialists
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Chicago RidgeUnited StatesRecruiting
The Urology Group (Solaris)
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CincinnatiUnited StatesRecruiting
University of Cincinnati Cancer Center
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CincinnatiUnited StatesRecruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
Urology Center of Iowa Research
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CliveUnited StatesRecruiting
Ohio State University
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ColumbusUnited StatesRecruiting
UT Southwestern Medical Center
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DallasUnited StatesRecruiting
Urology Clinics of North Texas, PLLC
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DallasUnited StatesRecruiting
Central Ohio Urology Group (US Urology Partners)
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GahannaUnited StatesRecruiting
University of Florida
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GainesvilleUnited StatesRecruiting
The Conrad Pearson Clinic (Urology America)
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GermantownUnited StatesRecruiting
Banner MD Anderson Cancer Center
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GilbertUnited StatesRecruiting
UroPartners
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GlenviewUnited StatesRecruiting
Urology of Indiana, LLC (US Urology Partners)
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GreenwoodUnited StatesRecruiting
Hackensack University Medical Center
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HackensackUnited StatesRecruiting
Chesapeake Urology Research Associates
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HanoverUnited StatesRecruiting
Penn State University Milton S. Hershey Medical Center
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HersheyUnited StatesRecruiting
Houston Methodist
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HoustonUnited StatesRecruiting
City of Hope
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IrvineUnited StatesRecruiting
Mayo Clinic Florida
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JacksonvilleUnited StatesRecruiting
First Urology, PSC
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JeffersonvilleUnited StatesRecruiting
Southern Urology (Urology America)
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LafayetteUnited StatesRecruiting
Colorado Urology
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LakewoodUnited StatesRecruiting
Keystone Urology Specialists
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LancasterUnited StatesRecruiting
Advanced Urology Institute (Solaris)
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LargoUnited StatesRecruiting
Accellacare
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LisleUnited StatesRecruiting
Arkansas Urology
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Little RockUnited StatesRecruiting
University of Arkansas for Medical Sciences
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Little RockUnited StatesRecruiting
Urology Associates, Lone Tree
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Lone TreeUnited StatesRecruiting
Genesis Research (Greater Los Angeles)
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Los AlamitosUnited StatesRecruiting
Advanced Urology
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Los AngelesUnited StatesWithdrawn
Urologic Specialists of Northwest Indiana (Solaris)
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MerrillvilleUnited StatesRecruiting
Urology Center of Southern California
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MurrietaUnited StatesRecruiting
Carolina Urologic Research Center, LLC
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Myrtle BeachUnited StatesRecruiting
Urology Associates PC
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NashvilleUnited StatesRecruiting
Ochsner Medical Center
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New OrleansUnited StatesRecruiting
Integrated Medical Professionals, PLLC (Solaris)
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New YorkUnited StatesRecruiting
Lowcountry Urology (Solaris)
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North CharlestonUnited StatesRecruiting
Adult and Adolescent Urology
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OmahaUnited StatesRecruiting
University of California Irvine
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OrangeUnited StatesRecruiting
Advanced Urology Institute
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OxfordUnited StatesRecruiting
University of Pennsylvania
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PhiladelphiaUnited StatesRecruiting
Mayo Clinic - Arizona
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PhoenixUnited StatesRecruiting
Portland VA
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PortlandUnited StatesRecruiting
Oregon Health Science University
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PortlandUnited StatesRecruiting
Associated Urologist of North Carolina (Solaris)
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RaleighUnited StatesRecruiting
Mayo Clinic - Rochester
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RochesterUnited StatesRecruiting
University of Rochester
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RochesterUnited StatesRecruiting
Comprehensive Urology
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Royal OakUnited StatesRecruiting
UC Davis
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SacramentoUnited StatesRecruiting
Urology San Antonio, PA dba USA Clinical Trials
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San AntonioUnited StatesRecruiting
Om Research
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San DiegoUnited StatesRecruiting
University of Southern California
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San DiegoUnited StatesRecruiting
Spokane Urology
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SpokaneUnited StatesRecruiting
Oregon Urology Institute
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SpringfieldUnited StatesRecruiting
Specialty Clinical Research of St. Louis
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St LouisUnited StatesRecruiting
Associated Medical Professionals of NY, PLLC (US Urology Partners)
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SyracuseUnited StatesRecruiting
SUNY Upstate
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SyracuseUnited StatesRecruiting
Advanced Urology Institute - Tallahassee (Solaris)
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TallahasseeUnited StatesWithdrawn
Montefiore Medical Center
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The BronxUnited StatesRecruiting
Genesis Research (Greater Los Angeles)
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TorranceUnited StatesRecruiting
Michigan Institute of Urology (Solaris)
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TroyUnited StatesRecruiting
Arizona Urology Specialty
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TucsonUnited StatesWithdrawn
Urology of Virginia
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Virginia BeachUnited StatesRecruiting
Wichita Urology Group
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WichitaUnited StatesRecruiting
Minnesota Urology
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WoodburyUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.