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

Available (expanded access)

Conditions studied: Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma, Urologic Cancer, Bladder Cancer

In brief

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.

Key facts

Study ID

NCT06443944

Run by

CG Oncology, Inc.

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment
• Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.
• Acceptable baseline organ function

You may not qualify if…

• Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer.
• 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.
• Has received systemic anticancer therapy, including investigational agents, within 4 weeks of Day 1
• Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 1 week after the last study treatment.

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Michael G. Oefelein Clinical Trials — Bakersfield, California, United States
• University of Southern California / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• McR, Llc. — Murrieta, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Advanced Urology Institute — Daytona Beach, Florida, United States
• Lakeland Regional Medical Center - Hollis Cancer Center — Lakeland, Florida, United States
• Advanced Urology Institute — Largo, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Uropartners c/o Associated Urological Specialists — Chicago Ridge, Illinois, United States
• UroPartners, LLC — Glenview, Illinois, United States
• Urologic Specialists of Northwest Indiana — Merrillville, Indiana, United States
• Urology Center of Iowa Research — Clive, Iowa, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Michigan Institute of Urology, PC — Troy, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• The Urology Group, P.C. — Southaven, Mississippi, United States
• Integrated Medical Professionals, PLLC — New York, New York, United States
• MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States
• Lowcountry Urology Clinics, PA — North Charleston, South Carolina, United States
• Urology Partners of North Texas Research Institute — Arlington, Texas, United States
• Urology Clinics of North Texas — Dallas, Texas, United States
• Urology San Antonio, PA dba USA Clinical Trials — San Antonio, Texas, United States
• Digestive Health Research of North Texas — Wichita Falls, Texas, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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