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CAR T-cell Therapy
Engineered T Cell Therapy for Breast Cancer
Phase 1
Waitlist Available
Led By Daphne Stewart, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at pre-treatment and 6 months post-treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Antitumor activity
Change in NY-ESO-1-specific TCR-engineered T cells
Change in PD-1 expression on T cells
+1 moreTrial 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
Ultrasound Imaging
2018
Completed Phase 4
~730
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Echocardiography
2013
Completed Phase 4
~11670
Aldesleukin
2012
Completed Phase 4
~1620
Cyclophosphamide
1995
Completed Phase 3
~3770
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1730
Leukapheresis
2016
Completed Phase 2
~690
Fludarabine
2012
Completed Phase 3
~1100
Mammogram
2016
N/A
~10
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,268 Total Patients Enrolled
12 Trials studying Breast Cancer
4,544 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,628 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Daphne Stewart, MDPrincipal InvestigatorUniversity of Southern California
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.I am not on high-dose steroids or other drugs that weaken my immune system.My heart pumps blood effectively.You have a disease that can be measured using a specific set of guidelines.My kidney function tests are within the required range.I haven't had a heart attack, stroke, or serious heart rhythm problems in the last year.You must have at least 500 lymphocytes per microliter of blood.My TNBC has not responded to 2-3 standard treatments, including immunotherapy and chemotherapy.I am a woman aged 18 or older.My breast cancer is triple-negative.I had major surgery over 4 weeks ago or minor surgery over 2 weeks ago, not including tissue sample collection for this study.Your platelet count is at least 100,000 per cubic millimeter.I haven't had radiation, chemotherapy, or experimental drugs in the last 2 weeks.I was born with a long QT interval.I have taken cyclophosphamide in the last 4 months.I have severe heart disease.My cancer has spread to my brain or the lining around my brain.I do not have any severe health issues that could interfere with the study.You are allergic to cyclophosphamide or fludarabine.You are expected to live for at least 6 more months.You have a history of a weak immune system or an autoimmune disease.I have had issues with bleeding, ulcers, or holes in my stomach or intestines.Your heart's electrical activity (QT interval) is longer than normal when measured with specific levels of potassium and magnesium in your blood.Your hemoglobin level should be at least 9.0 grams per deciliter.I am currently using alternative or complementary medicines.My cancer cells show high levels of NY-ESO-1 and I am HLA-A2 positive.I am fully active or can carry out light work.Your bilirubin levels are less than twice the upper limit of normal.My liver enzymes are within the required range for the study.Your white blood cell count is between 2500 and 15000 per microliter.You have enough infection-fighting white blood cells in your body.I have liver disease not caused by cancer spread.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (A2-ESO-1 TCR-T cells)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary aims of this medical research effort?
"This experiment, with a follow-up period of 8 weeks after A2-ESO-1 TCR infusion, is primarily evaluating the incidence of dose-limiting toxicities. Additionally, secondary objectives comprise assessing PD-1 expression on T cells via one sided paired t tests and Wilcoxon signed rank tests to observe NY-ESO -specific TCR engineered cell levels as well as regulatory T cell counts over time."
Answered by AI
Are new participants currently being recruited for this scientific experiment?
"Per the listing on clinicaltrials.gov, this trial has already concluded its patient recruitment phase. Initially posted on September 18th 2023 and last edited on August 9th 2023, the study no longer seeks participants; however, there are 2,442 other studies actively seeking patients at present."
Answered by AI
Is the A2-ESO-1 TCR-T cell therapy a viable option for patients with respect to safety?
"The A2-ESO-1 TCR-T cells have been judged to be of low risk, as evidenced by their score of 1 on our Power scale. This is due to the fact that this stage one trial has limited evidence backing its safety and efficacy."
Answered by AI
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