Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder Cancer

NCT02143804 | Withdrawn Phase 2

• 1 other identifier: exBOND 2.1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oncolytic virus; GMCSF; pRb; PDL1; Immunotherapy; Adenovirus

Outcome Measures

Primary Outcomes (1)

• Durable Complete Response Proportion

  DCR

  15 month time point from the date of the first intravesical treatment and/or at least 12 months from the initial complete response assessment (3 months from first intravesical treatment) or any time after

Study Arms (1)

CG0070

EXPERIMENTAL

oncolytic virus genetically modified to express GM-CSF

Biological: oncolytic adenovirus expressing GMCSF

Interventions

oncolytic adenovirus expressing GMCSF BIOLOGICAL

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.

Also known as: CG0070, Adenovirus with GMCSF expression, DDM

CG0070

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have pathologically confirmed high grade disease (HG), as defined by the 2004 WHO classification system
• Patients must have no evidence of muscle invasive disease
• Patient must fall under one of the following criteria:
• Patients who were first enrolled in the BOND protocol but have failed to achieve a complete response or have relapsed following a complete response at 3 months after receiving control treatments
• OR patients who were first enrolled in the BOND protocol but have relapsed following a complete response lasting over a year after receiving CG0070 treatments
• OR patients who have Ta/T1 high grade, refused cystectomy and are CG0070 naïve
• OR patients from the exBOND protocol who experienced a tumor relapse with no disease progression after sustaining 12 months or longer complete response duration
• For Cis patients or Cis with Ta and/or T1 only:
• Tumor must be considered unresectable or with residual disease.
• Patients must be declared as medically unfit for cystectomy.
• No disease progression from disease status at the beginning of the BOND trial.
• For Ta/T1 HG Patients:
• They must have also received at least one prior course of BCG therapy per the recommended schedules. Patients can have either failed BCG induction therapy within a six-month period or have been successfully treated with BCG, but subsequently found to have recurrence. The standard course of intravesical BCG therapy must include at least six weekly treatments (allowable range of instillations per course is 4-9) within a six-month period
• They must have received 2 or more intravesical chemotherapy regimens other than BCG
• They must have relapsed within 6 months of their last treatment

You may not qualify if:

• Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable
• History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products, clinically meaningful allergic reactions or any known hypersensitivity or prior reaction to any of the formulation excipients in the study drugs.
• Known infection with HIV, HBV or HCV.
• Anticipated use of chemotherapy, radiotherapy, or other immunotherapy not specified in the study protocol while on study
• Any underlying medical condition that, in the Investigator's opinion, will make the administration of study vector hazardous to the patient, would obscure the interpretation of adverse events, or not permit adequate surgical resection.
• Systemic treatment on any investigational clinical trial within 28 days prior to registration.
• Concurrent treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (exception: inhaled or topically applied steroids, and acute and chronic standard dose NSAIDs, are permitted). Use of a short course (i.e., ≤ 1 day) of a glucocorticoid is acceptable to prevent a reaction to the IV contrast used for CT scans.
• Immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry.
• History of prior experimental cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine)
• History of stage III or greater cancer, excluding urothelial cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer, must have been adequately treated and have been disease-free for ≥ 3 years at the time of registration.
• Progressive viral or bacterial infection
• o All infections must be resolved and the patient must remain afebrile for seven days without antibiotics prior to being placed on study
• Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel
• Evidence of disease progression compared to disease status before BOND protocol for NMIBCis patients.
• Patient have relapsed less than 1 year after or who are refractory to treatment with CG0070.

Sponsors & Collaborators

• CG Oncology, Inc.: lead

Study Sites (1)

BCG Oncology

Phoenix, Arizona, 85032, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Adenoviridae Infections

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 21, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (1)