Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder Cancer
NCT02143804 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2026-04-02
Summary
This is an expanded access protocol to study the safety and efficacy of CG0070 in Cis and Cis with Ta and/or T1 disease patients who failed both BCG therapy and the BOND protocol (NCT 01438112), or in high grade Ta and T1 patients who failed BCG therapy.
Conditions
- Bladder Cancer
- High Grade
- Non Muscle Invasive
Interventions
- BIOLOGICAL
-
oncolytic adenovirus expressing GMCSF
Treatment once weekly by intravesical route. Use of DDM to first remove the GAG layer of the bladder and to improve virus transduction. Installation of 100 ml. of CG0070 at 10e12 viral particles for 45 minutes inside bladder.
Sponsors & Collaborators
-
CG Oncology, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2015-03-31
- Completion
- 2015-03-31
Countries
- United States
Study Locations
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