CG Oncology CRETO-EAP
An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
Brief Summary
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.
Additional Resources
Eligibility Criteria
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.
Last Updated: 12/12/2025
This website provides general information about the clinical trial for informational purposes only. For complete and up-to-date details, please refer to the official listing on ClinicalTrials.gov.
