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Phase 2 Study of Cretostimogene Grenadenorepvec for High-Risk Bladder Cancer

This Phase 2 study is testing a drug called Cretostimogene Grenadenorepvec for people with high-risk non-muscle-invasive bladder cancer (NMIBC). This type of cancer is found in the bladder lining and hasn't spread into the muscle. The study aims to see how safe and effective Cretostimogene Grenadenorepvec is. You might be able to join if you are 18 or older and have high-risk NMIBC that has not been treated with BCG (Bacillus Calmette-Guerin) or has been treated with BCG before. Researchers will measure how many participants have a complete response (meaning the cancer is no longer detectable) at 11 and 24 weeks, and how long participants live without high-grade cancer events for up to 48 months. The study is currently recruiting up to 325 participants.

Study design
This is a Phase 2, multi-arm, multi-cohort, open-label study. It plans to enroll up to 325 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
For some participants, researchers will track how long they live without high-grade cancer events for up to 48 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06567743

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
CG Oncology, Inc.
~325 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:Cretostimogene Grenadenorepvec

At a glance

Recruiting sites
76 of 80 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort A (Arm 1 and 2): Complete response rate
Measured over At 11 and 24 weeks
+5 more outcomes measured

Conditions

High-Risk Non-Muscle-Invasive Bladder Cancer

Explore related trials

Bladder CarcinomaNon-Muscle Invasive Bladder Carcinoma

NCT06567743

Where you'd take part

This study runs at 80 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Accellacare

    Lisle, Illinoisstudy coordinator listed

    Recruiting

  • Adult and Adolescent Urology

    Omaha, Nebraskastudy coordinator listed

    Recruiting

  • Advanced Urology Institute

    Oxford, Floridastudy coordinator listed

    Recruiting

  • Advanced Urology Institute (Solaris)

    Largo, Floridastudy coordinator listed

    Recruiting

  • Anne Arundel Urology

    Annapolis, Marylandstudy coordinator listed

    Recruiting

  • Arkansas Urology

    Little Rock, Arkansasstudy coordinator listed

    Recruiting

  • Associated Medical Professionals of NY, PLLC (US Urology Partners)

    Syracuse, New Yorkstudy coordinator listed

    Recruiting

  • Associated Urological Specialists

    Chicago Ridge, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Vijay Kasturi, MD · STUDY_DIRECTOR · CG Oncology

Who to contact

Rebecca Tregunna, MD
[email protected]
949 409-3700
Email the study team

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Eligibility criteria

Inclusion

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.
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.
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.

Exclusion

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

What this trial measures

  • Cohort A (Arm 1 and 2): Complete response rateAt 11 and 24 weeks

    Determine the complete response rate at any time following treatment with cretostimogene in participants with BCG-naïve CIS with or without concomitant high-grade Ta or T1 disease at baseline

  • Cohort A (Arm 3): High- Grade Event-Free Survival48 months

    Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-naïve HG Ta/T1 disease without concomitant CIS at baseline.

  • Cohort B (Arm 1): Complete response rateAt 11 and 24 weeks

    Determine the complete response rate at any time following treatment with cretostimogene in participants with BCG-exposed CIS with or without concomitant high-grade Ta or T1 disease at baseline.

  • Cohort B (Arm 2): High-Grade Event-Free Survival48 months

    Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed high-grade Ta/T1 papillary disease without CIS at baseline.

  • Cohort CX (Arms 1 and 2): High-Grade Event-Free Survival48 months

    Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed or BCG-unresponsive high-grade NMIBC.

  • Cohort CX (Arms 1 and 2): Safety48 months

    Determine the safety of concurrent cretostimogene and gemcitabine and sequential cretostimogene and gemcitabine.