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CAR T-cell Therapy

Engineered T Cell Therapy for Breast Cancer

Phase 1

Waitlist Available

Led By Janice Lu, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cardiac ejection fraction >= 50%

Creatinine (Cr) < 2 x upper limit of normal (ULN), and Cr clearance (CrCl) >= 50 mL/min by Cockcroft and Gault

Must not have

Females who are pregnant or breastfeeding

Current use of medications that interact with or compromise the immune system such as steroid doses > 10 mg/day prednisone or equivalent daily within 2 weeks before leukapheresis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at pre-treatment and 6 months post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special type of immune cell therapy to treat TNBC that has come back or does not respond to treatment. Chemotherapy drugs and IL-2 help the T cells attack and kill tumor cells that express NY-ESO-1.

Who is the study for?

This trial is for women over 18 with advanced or metastatic triple negative breast cancer that's resistant to standard treatments. They must have a certain immune system status, organ function, and life expectancy. Participants need HLA-A2+ status and NY-ESO-1 tumor expression. Pregnant or breastfeeding women can't join, nor those with recent heart issues, brain metastases, severe medical conditions, or allergies to the study drugs.

What is being tested?

The trial tests engineered T cells designed to target NY-ESO-1 on tumor cells in patients whose cancer has returned or doesn't respond to treatment. It includes chemotherapy (cyclophosphamide and fludarabine) before T cell infusion and aldesleukin after to boost effectiveness.

What are the potential side effects?

Possible side effects include reactions related to immune response such as fever and fatigue; complications from chemotherapy like nausea; potential tissue damage at the site of infusion; increased risk of infection due to altered immune cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart pumps blood effectively.

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My kidney function tests are within the required range.

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My TNBC has not responded to 2-3 standard treatments, including immunotherapy and chemotherapy.

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I am a woman aged 18 or older.

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My breast cancer is triple-negative.

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My cancer cells show high levels of NY-ESO-1 and I am HLA-A2 positive.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I am not pregnant or breastfeeding.

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I am not on high-dose steroids or other drugs that weaken my immune system.

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I was born with a long QT interval.

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I have severe heart disease.

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My cancer has spread to my brain or the lining around my brain.

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I do not have any severe health issues that could interfere with the study.

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I have had issues with bleeding, ulcers, or holes in my stomach or intestines.

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I am currently using alternative or complementary medicines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at pre-treatment and 6 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at pre-treatment and 6 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at pre-treatment and 6 months post-treatment 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 dose-limiting toxicities

Maximum tolerated dose (MTD) of anti-HLA-A2/NY-ESO-1 T-cell receptor (TCR)-transduced autologous T lymphocytes (A2-ESO-1 TCR-engineered T cells)

Secondary study objectives

Antitumor activity

Change in NY-ESO-1-specific TCR-engineered T cells

Change in PD-1 expression on T cells

+1 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 (A2-ESO-1 TCR-T cells)Experimental Treatment13 Interventions

Patients undergo leukapheresis on day -28 then receive cyclophosphamide IV over 1 hour on days -7 and -6 followed by fludarabine IV over 30 minutes on days -5 to -1. Patients then receive A2-ESO-1 TCR-T cells IV over 30 minutes on day 0 followed by aldesleukin IV over 15 minutes on days 0 to 2. Patients also undergo blood sample collection and CT scans throughout the study. Additionally, patients may undergo a breast biopsy, a mammogram, breast MRI, and breast US at screening and follow up, and ECHO or MUGA at screening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Biospecimen Collection

2004

Completed Phase 3

~2020