AzTrials
AzTrials

Bladder CancerPhase 2exBONDNCT02143804

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

A Phase 2 study testing oncolytic adenovirus expressing GMCSF in people with Bladder Cancer and High Grade, run by CG Oncology, Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer, High Grade, Non Muscle Invasive
What is being tested?
oncolytic adenovirus expressing GMCSF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Mar 2014to Mar 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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
Show all 28Show fewer
  • 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
  • 18 years of age or older
  • Radical cystectomy has been declined by the patient in a signed special section of the informed consent, whereby there is a clear explanation by the investigator to the subject that a delay of cystectomy may increase his/her chance of disease progression, the results of which may lead to serious and life threatening consequences.
  • Patients must be able to enter into the study within five weeks of their most recent diagnostic procedure, which is usually a diagnostic biopsy, a transurethral resection of bladder tumor (TURBT) procedure or other diagnostic scanning such as CT and PET procedures.
  • Histopathologically confirmed, transitional cell (urothelial) carcinoma. Urothelial tumors with mixed histology (but with <50% variant) are eligible.
  • Eastern Cooperative Oncology Group (ECOG) performance status <2.
  • Not pregnant or lactating
  • Patients with child bearing potential must agree to use adequate contraception
  • Agree to study specific informed consent and HIPAA authorization for release of personal health information
  • Adequate baseline CBC, renal and hepatic function. Parameters described as .WBC>3000 cells/mm3, ANC>1,000 cells/mm3, hemoglobin>10g/dL, and platelet count >100,000 cells/mm3
  • Adequate renal function: serum creatinine <2.0mg/dL
  • Bilirubin, AST and ALT not more than 2 x Upper Limits of Normal
  • PT/INR, PTT, and fibrinogen within institutional normal limits
  • Absolute lymphocyte count ≥ 800/μL before the first dose of CG0070

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.
  • Cis, and Cis with Ta and/or T1 patients who are medically fit for cystectomy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • BCG Oncology

    Phoenix, Arizona, 85032

Other trials in United States

About this study

Official title: Phase II Safety and Efficacy Study of CG0070 Oncolytic Vector Regimen in Patients With High Grade Non-Muscle Invasive Bladder Carcinoma Disease (NMIBC) Who Have Failed BCG and Refused Cystectomy

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.

Read the detailed description

The plan is to study the safety and efficacy of CG0070 in high-grade NMIBC patients who failed BCG therapy. Most patients with NMIBCis (Cis, Cis with Ta and/or T1, high grade Ta or T1 with frequent or uncontrolled recurrences) who have failed BCG intravesical therapy (standard of care) usually have no other choice but to proceed to cystectomy. Cystectomy is a surgery associated with major morbidity, mortality and quality of life issues. Morbidity and long term tedious medical care will be for the rest of the patient's life span. Most patients at this stage do not show signs of disease progression into the muscle layer or of metastasis, making surgery a very difficult decision. CG0070, if successful in this trial, will serve to provide a therapeutic alternative for this patient population in need. For the present study, Cis or Cis with Ta and/or T1 patients can only be enrolled if they have failed the BOND study and are medically unfit for surgery. Furthermore, patients with high grade Ta or T1 disease who have failed both BCG and chemotherapy treatments are also prone to disease progression. Since these patients are not eligible to be enrolled in the BOND trial, the present study will serve as an alternative to access CG0070 experimental treatment.

Being tested
oncolytic adenovirus expressing GMCSF
Keywords
Oncolytic virus, GMCSF, pRb, PDL1, Immunotherapy, Adenovirus
Medical subject headings
Urinary Bladder Neoplasms, Adenoviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oncolytic adenovirus expressing GMCSFBiological

    Also called CG0070, Adenovirus with GMCSF expression, DDM

    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.

Study groups in NCT02143804
Study groupRoleWhat they receive
CG0070Experimentaloncolytic virus genetically modified to express GM-CSF
Receives: Biological: oncolytic adenovirus expressing GMCSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Durable Complete Response Proportion

    DCR

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionMar 2015
  4. Study completionMar 2015

Why it stopped: Change in trial design

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02143804
Sponsor's protocol ID
exBOND 2.1
Acronym
exBOND
Status last verified
Mar 2026
First submitted
19 May 2014
Last updated
2 Apr 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oncolytic adenovirus expressing GMCSF in people with Bladder Cancer and High Grade, run by CG Oncology, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Durable Complete Response Proportion (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02143804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in