October is National Breast Cancer Awareness Month, so Alliance for Cancer Gene Therapy is highlighting the progress in developing cell and gene therapies for this challenging cancer and underscoring the importance of clinical trials for both patients who are seeking more treatment options and researchers committed to improving lives.
Cell and gene therapy harnesses the power of the human immune system to destroy cancer cells. Scientists use cell and gene therapy to activate the immune system to more effectively find and eliminate cancer cells while not harming healthy tissue. There are several cell and gene therapies approved by the FDA for blood cancers such as leukemia, lymphoma, and multiple myeloma.
Breast cancer is the second leading cause of cancer death in women and, according to the American Cancer Society, women in the United States have on average a 1 in 8 chance of developing this disease. Metastatic breast cancer, meaning cancer initially located in the breast that has spread to other areas of the body, is the leading cause of breast cancer deaths.
As research into cell and gene therapies for solid tumors makes progress, there are new opportunities for patients to participate in breast cancer clinical trials that test CAR T-cell therapy and other approaches to empower the immune system to find and destroy cancer cells.
Cell and gene therapy clinical trials for breast cancer
Clinical trials are a critical part of how new therapies are developed and, for people with hard-to-treat or recurrent cancers (cancers that were not eliminated from treatment and began spreading again), they are a way for patients to access new approaches like CAR T-cell therapy and other emerging immunotherapies.
The cell and gene therapy trials listed below are actively recruiting patients with breast cancer and, while still in early stages of research, are showing some promising results.
Links are provided to each clinical trial’s page on clinicaltrials.gov where patients can find detailed enrollment criteria and contact information for each trial.
Clinical trial for people with triple negative breast cancer
ROR1 is a protein expressed by many aggressive solid tumors, including in approximately 60% of patients with triple-negative breast cancer (TNBC). Lyell Therapeutics is testing LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1-positive relapsed or refractory TNBC. The trial is available in multiple hospitals across the United States.
Clinical trial for people with advanced triple negative, ROR-1-positive breast cancer
This clinical trial, at Moffit Cancer Center in Florida, is testing if a CAR T-cell therapy called PRGN-3007 UltraCAR-T cells can help people with ROR1-positive cancers, including triple negative breast cancer.
Clinical trial for people with metastatic breast cancer, also known as stage 4 breast cancer
Minerva Therapeutics launched a first-in-human clinical trial at City of Hope in Duarte, California, in 2022. The clinical trial is testing a CAR T-cell therapy, called huMNC2-CAR44, for patients with metastatic breast cancer. The CAR T-cell therapy targets a protein called MUC 1 star that functions as a growth factor receptor and is present on large percentage of solid tumors, including approximately 90% of breast tumors.
Clinical trial for people with metastatic HER 2-positive breast cancer
This trial at Baylor Medical Center in Texas is studying a CAR T-cell therapy combined with an oncolytic virus injected directly into tumors for patients with metastatic HER2-positive breast cancer. The study will determine whether the two cell and gene therapies combined are more effective than using just one of them.
Clinical trial for people with HER2-positive breast cancer with brain metastases
This phase 1 trial studies the side effects and best dose of HER2-CAR T cells in treating patients with cancer that has spread to the brain or leptomeninges and has come back (recurrent). HER2-CAR T cells delivered into the ventricles of the brain may recognize and kill tumor cells.
Clinical trial for people with breast cancer that expresses mesothelin
This phase 1 clinical trial at University of Pennsylvania is testing the safety and feasibility of a CAR T-cell therapy, called huCART-meso cells. This trial is for patients with advanced (stage 3) or metastatic (stage 4) triple negative (ER-, PR- or HER2-positive) breast cancer that expresses the protein mesothelin.
Clinical trial for people with metastatic breast cancer that tests positive for CD70
At the National Institutes of Health, a phase 1/2 trial of a CD70-binding CAR T-cell therapy is being tested in patients with CD70-expressing cancers, including metastatic breast cancer.
Clinical trial for people with advanced breast cancer that tests positive for GD2
This CAR T-cell therapy clinical trial, at Baylor College of Medicine, is for patients with a type of cancer, including breast cancer, that expresses a protein on the cancer cells called GD2. The cancer has either come back after treatment (recurrent) or did not respond to treatment (resistant/refractory).
About Alliance for Cancer Gene Therapy
Alliance for Cancer Gene Therapy funds research that helps advance new cell and gene therapies for all solid tumors, including breast cancer. You can make a donation here or sign up for our monthly newsletters to keep up with our progress. 100% of donations supports research and programs.