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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

Must not have

Active infection requiring antibiotics

Clinically significant uncontrolled illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking antibiotics for an infection.

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I do not have any uncontrolled serious illnesses.

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My brain cancer has not been stable.

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I have had cancer recently, but it was not skin cancer.

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I have had major surgery or radiation therapy recently.

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I have a history of HIV, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

Clinical benefit rate

Duration of response

Event-free survival

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met