Is NCT05989828 recruiting in Los Angeles, CA?

Yes, NCT05989828 is currently recruiting participants at its Los Angeles, CA location. This triple negative breast cancer clinical trial is actively enrolling qualified participants.

How do I join the triple negative breast cancer clinical trial in Los Angeles?

To join this clinical trial in Los Angeles, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Los Angeles clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Triple Negative Breast Cancer Clinical Trial in Los Angeles, CA

About This Triple Negative Breast Cancer Study in Los Angeles

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.

Sponsor: University of Southern California

Who Can Participate

Inclusion Criteria

Female aged \>= 18 years

Histologically confirmed advanced or metastatic TNBC that have relapsed on or are refractory to 2 or more lines of standard-of-care therapy. TNBC is defined as estrogen receptor (ER) and progesterone receptor negative (\< 10% immunohistochemistry \[IHC\] staining) and HER2 negative (IHC 1+ or 0 AND/OR in situ hybridization negative based on:

Single-probe average HER2 copy number \< 4.0 signals/cell

Dual-probe HER2/CEP17 ratio \< 2.0 with an average HER2 copy number \< 4.0 signals/cell)

HLA-A2+ and tumoral overexpression of NY-ESO-1 (2 to 3+ IHC staining in \> 50% of cells)

Have measurable disease based on RECIST 1.1

Life expectancy \>= 6 months

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Hemoglobin \>= 9.0 g/dL (transfusions permitted)

Absolute neutrophil count (ANC) \>= 1500/mm\^3

Platelet count \>= 100,000/mm\^3

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

Alanine transaminase (ALT) and aspartate transaminase (AST) \< 2 x ULN (Patients with liver metastases whose ALT/AST are \< 5 x ULN are eligible for enrollment)

Bilirubin \< 2 x ULN

Lymphocyte count \>= 500/uL

Cardiac left ventricular ejection fraction (LVEF) \>= 50%

Negative serum pregnancy (human chorionic gonadotropin \[beta-hCG\]) test within 7 days of leukapheresis for women of childbearing potential (WOCBP). WOCBP must be willing to use a highly effective method of contraception for the course of the study through 90 days after A2-ESO-1 TCR-engineered T cell infusion

Willing and able to provide written informed consent for the study

Willing to provide biopsy tissues and blood samples as required by the study

Exclusion Criteria

Radiation therapy, chemotherapy, or non-cytotoxic investigational agent within 2 weeks of leukapheresis

Received cyclophosphamide within the past 4 months

Evidence of New York Heart Association class III or greater cardiac disease

History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within the past 12 months

History of congenital QT prolongation

Absolute QT interval of \> 470 msec in the presence of \> 4.0 mEq/L potassium and \> 1.8 mg/dL magnesium

Brain or leptomeningeal metastases

Females who are pregnant or breastfeeding

Hypersensitivity or intolerance to cyclophosphamide, fludarabine, IL-2, or their components

History of clinically significant gastrointestinal bleeding, gastric or intestinal ulceration, or perforation within 6 months of enrollment.

Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study, such as severely impaired lung function, any active (acute or chronic) or uncontrolled infection/disorders, and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the study treatment

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

History of immunodeficiency disease or autoimmune disease, with exceptions such as Hashimoto's thyroiditis / hypothyroidism, or controlled Type 1 diabetes

Have any active and uncontrolled infection.

Active hepatitis B (as defined as positive hepBsAntigen or detectable hepatitis B DNA) or hepatitis C infection. Patients who are hepatitis B surface Antigen negative and have a negative hep B DNA are allowed. If hepatitis C antibody test is positive, then patients must be tested for the presence of antigen by RT-PCR and be HCV RNA negative. Patients with laboratory evidence of cleared hepatitis B or C infection may enroll. Patients with no prior history of hepatitis B infection who have been vaccinated against hepatitis B and who have a positive antibody against hepatitis B surface antigen as the only evidence of prior exposure may enroll. Patients with a history of hepatitis C infection may be eligible if they have completed antiviral treatment and show no detectable HCV RNA for 6 months prior to enrollment.

Human immunodeficiency virus (HIV) infection or seropositive for HIV antigens

Concurrent use of any complementary or alternative medicines

Unwilling or unable to comply with the study protocol

Prior major surgery that requires general anesthesia must be completed at least 4 weeks before leukapheresis and surgery that requires local anesthesia (except for study tissue sample collection) must be completed at least 2 weeks before leukapheresis and surgery that requires local anesthesia (except for study tissue sample collection) must be completed at least 2 weeks before leukapheresis

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Los Angeles?

Yes, this clinical trial (NCT05989828) has an active research site in Los Angeles, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Triple Negative Breast Cancer Treatment Options in Los Angeles, CA

If you're searching for triple negative breast cancer treatment options in Los Angeles, CA, this clinical trial (NCT05989828) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Los Angeles research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced triple negative breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all triple negative breast cancer clinical trials near you to find additional studies recruiting in your area.

Triple Negative Breast Cancer Clinical Trial in Los Angeles, CA

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