A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer

Summary

This phase Ib trial tests the safety, side effects and best dose of anti-HLA-A2/NY-ESO-1 T-cell receptor (TCR)-transduced autologous T lymphocytes (A2-ESO-1 TCR-T cells) in treating patients with NY-ESO-1 overexpression positive triple negative breast cancer (TNBC) that has come back after a period of improvement (relapsed/recurrent) or that does not respond to treatment (refractory), and that may have spread from where it first started (primary site) to nearby tissue, lymph nodes (advanced) or to other places in the body (metastatic). NY-ESO-1 is an antigen found on the surface of many different types of tumor cells including TNBC. Antigens make it possible for immune cells to recognize and kill germ cells that invade the body, however, it is more difficult for immune cells to recognize antigens on tumor cells. T cells are a special type of immune cell in the blood. These T cells may be trained to recognize the NY-ESO-1 antigen on tumor cells, allowing the T cells to attack and kill those tumor cells. The A2-ESO-1 TCR-T cells are T cells that have been removed from the patient's blood through a process called leukapheresis and then changed in the laboratory to recognize NY-ESO-1 on tumor cells. When given back to the patient, these A2-ESO-1 TCR-T cells find and attack tumor cells that express NY-ESO-1. Chemotherapy drugs, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. They are given before the T cells to support optimum activity of the A2-ESO-1 TCR-T cells. IL-2 (aldesleukin) is in a class of drugs known as cytokines. It is a man-made version of a naturally occurring protein that stimulates the body to produce other chemicals which increase the body's ability to fight cancer. A2-ESO-1 TCR-T cells may kill more tumor cells in patients with recurrent or refractory advanced or metastatic TNBC that overexpresses NY-ESO-1.

Conditions

• Triple Negative Breast Cancer

Interventions

BIOLOGICAL

Aldesleukin

Given IV

BIOLOGICAL

Anti-HLA-A2/NY-ESO-1 TCR-transduced Autologous T Lymphocytes

Given IV

PROCEDURE

Biopsy

Undergo biopsy of breast tumor

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Echocardiography

Undergo ECHO

DRUG

Fludarabine

Given IV

PROCEDURE

Leukapheresis

Undergo leukapheresis

PROCEDURE

Magnetic Resonance Imaging

Undergo breast MRI

PROCEDURE

Mammogram

Undergo mammogram

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

PROCEDURE

Ultrasound Imaging

Undergo ultrasound of breast

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Southern California

  lead OTHER

Principal Investigators

• Daphne Stewart, MD · University of Southern California

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-17

Primary Completion

2027-12-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States

Study Locations