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

Launched by CG ONCOLOGY, INC. · May 30, 2024

Keywords

ClinConnect Summary

All participants will be assigned the same treatment schedule. Participants will receive an induction course of 6 weekly treatments, and, if there is no disease recurrence at Week 13, participants will receive a cycle of 3 weekly treatments up to Week 15.

If there is persistent HG Ta and/or CIS at Week 13, participants may receive a second induction cycle.

If the participant has persistent but improved HG Ta and/or CIS at Week 25 or a later timepoint, the participant may receive a cycle of 3 weekly treatments of cretostimogene at the discretion of the Investigator provided that T1 or high...

Gender

ALL

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.