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CAR T-cell Therapy

T-Cell Therapy for Breast Cancer

Phase 1

Waitlist Available

Led By Shanu Modi, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Chemotherapy, targeted therapy (such as a tyrosine kinase inhibitor), or radiotherapy must have been completed at least 14 days before administration of T-cells. Prior immunotherapy with checkpoint blockade (i.e., PD1 inhibitor, PDL1 inhibitor, or CTL4-antagonist or similar agent) must have been completed more than 1 month before the T-cell infusion.

Breast cancer pathologically confirmed at MSKCC or outside institutions for screening phase

Must not have

Known active infection requiring antibiotics within 7 days of treatment start

Autoimmune or antibody-mediated disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of different doses of T cells that have been collected from the blood and modified to target HER2-negative breast cancer cells. The goal is to find a safe dose of these modified T cells that can be used to treat patients with metastatic breast cancer.

Who is the study for?

This trial is for adults with advanced HER2-negative breast cancer who've had at least one chemo treatment and whose disease has progressed. They must have finished any previous treatments, including immunotherapy, certain days before getting T-cells and agree to use contraception. People can't join if they're on daily steroids, have autoimmune diseases, are pregnant or breastfeeding, or have untreated brain metastases.

What is being tested?

The study tests different doses of modified T cells targeting mesothelin in patients with metastatic breast cancer to find a safe level. Patients will receive Cyclophosphamide followed by the engineered T cells and AP1903 as part of the treatment process.

What are the potential side effects?

Potential side effects may include immune reactions due to the modified T cells attacking normal tissues, infusion-related symptoms like fever or chills, fatigue from Cyclophosphamide, and possible complications related to AP1903 administration.

Eligibility Criteria

Inclusion Criteria

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

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I finished chemotherapy, targeted therapy, or radiotherapy at least 14 days ago and any immunotherapy over a month ago.

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My breast cancer diagnosis was confirmed through a biopsy.

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I am 18 or older with breast cancer that has spread.

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My latest cancer test shows I am HER2 negative.

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I have had chemotherapy for my cancer that has spread, and it has gotten worse.

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I am able to care for myself but may not be able to do active work.

Exclusion Criteria

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

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I have not taken antibiotics for an infection in the last 7 days.

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I have an autoimmune or antibody-mediated disease.

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I have brain metastases that haven't been treated.

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I have a history of seizures.

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I have serious heart or severe lung problems.

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I have not received a live vaccine within the last 8 weeks.

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I am currently receiving treatment for another cancer.

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I take daily medication to suppress my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Maximum tolerated does (MTD)

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: T-cell infusionExperimental Treatment3 Interventions

A single blood volume leukapheresis for harvesting of PBMCs will be performed, As the transduced T cells will be frozen, the timing of leukapheresis is not defined \& can vary from patient to patient. Subsequently, a single dose of mesothelin-targeted T cells will be infused via intravenous catheter or central line (i.e., mediport). Patients will be monitored in the hospital and discharged home after a minimum of 48 hours. Patients will be monitored closely as outpatients for the next 2 months. Patients will be followed weekly as outpatients for the first 8 weeks after treatment. All patients will be hydrated intravenously, premedicated with acetaminophen \& diphenhydramine, \& administered cyclophosphamide at 1.5 g/m2 2 to 7 days (Day -7 to Day -2) before administration of mesothelin-targeted T cells.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

AP1903

2014

Completed Phase 2

~90