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Virus Therapy

Oncolytic Virus CF33-expressing hNIS/Anti-PD-L1 Antibody for Breast Cancer

Phase 1
Waitlist Available
Led By Yuan Yuan
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed metastatic triple negative breast cancer meeting specific criteria
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new virus that is designed to infect and break down tumor cells in patients with metastatic triple negative breast cancer.

Who is the study for?
This trial is for adults with metastatic triple negative breast cancer who have tried at least two treatments without success. Participants must not be pregnant, breastfeeding, or have other cancers; they should also agree to use birth control and provide biopsies. They need normal blood counts, liver function within certain limits, and cannot join if they've had recent vaccines or infections.Check my eligibility
What is being tested?
The trial tests CF33-hNIS-antiPDL1, an oncolytic virus designed to infect and break down tumor cells in patients with advanced breast cancer. It's a phase I study focusing on the safety of this treatment and finding the right dosage.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to immune therapies such as flu-like symptoms, fatigue, fever, chills, nausea. Since it involves a virus that targets cancer cells there might be localized pain or inflammation where the injection is given.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is triple negative and has spread to other parts.
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I am 18 years old or older.
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My cancer can be safely treated with direct injections into the tumor.
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My condition worsened or I couldn't tolerate 2 previous treatments for my advanced cancer.
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I can perform all my self-care but may not be able to work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Clinical benefit rate
Duration of response
Event-free survival
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (CF33-hNIS-antiPDL1)Experimental Treatment1 Intervention
Patients receive CF33-hNIS-antiPDL1 IT on days 1 and 15. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

Find a Location

Who is running the clinical trial?

Imugene LimitedIndustry Sponsor
6 Previous Clinical Trials
339 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,451 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,144 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer

Media Library

CF33-hNIS-antiPDL1 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05081492 — Phase 1
Breast Cancer Research Study Groups: Treatment (CF33-hNIS-antiPDL1)
Breast Cancer Clinical Trial 2023: CF33-hNIS-antiPDL1 Highlights & Side Effects. Trial Name: NCT05081492 — Phase 1
CF33-hNIS-antiPDL1 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05081492 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants receiving treatment within this research project?

"Affirmative. According to clinicaltrials.gov, this trial is still open for enrolment since it was first published on October 18th 2021 and last updated March 3rd 2022. 78 participants are required from a single location."

Answered by AI

Is Oncolytic Virus CF33-expressing hNIS/Anti-PD-L1 Antibody a secure intervention for patients?

"While there is limited data on the efficacy of Oncolytic Virus CF33-expressing hNIS/Anti-PD-L1 Antibody, it has been evaluated as one out of three in terms of safety."

Answered by AI

Are any vacancies currently available in this clinical trial?

"According to the clinicaltrials.gov portal, this medical trial is actively recruiting candidates and has been since October 18th 2021. The study was recently updated on March 3rd 2022 as well."

Answered by AI

Who else is applying?

How old are they?
65+
What site did they apply to?
City of Hope Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer
2021. "CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05081492.
~1 spots leftby Sep 2024
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