T-Cell Therapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of a new treatment using modified T cells, which are special blood cells, to target metastatic breast cancer. The goal is to determine the right dose of these T cells for patients whose cancer lacks the HER2 protein. Participants should have breast cancer that has progressed after at least one round of chemotherapy and should express a protein called mesothelin on their cancer cells. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial requires that you stop chemotherapy, targeted therapy, or radiotherapy at least 14 days before receiving T-cells, and any prior immunotherapy must be completed more than a month before the T-cell infusion. If you are on daily systemic corticosteroids or other immunosuppressive agents, you will need to stop those as well.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that T cells targeting mesothelin have been safe in earlier studies. One study found that patients with various cancers, such as breast cancer, experienced no negative side effects after receiving these T cells. Another study tested the safety of these T cells in patients with solid tumors expressing mesothelin. These findings suggest the treatment is generally well-tolerated.
However, this trial remains in its early stages. Early trials primarily focus on safety, so while initial results appear promising, further testing is necessary to confirm them. Researchers will closely monitor participants to ensure their safety throughout the trial.12345Why are researchers excited about this trial's treatments?
Unlike standard treatments for breast cancer, which typically involve surgery, chemotherapy, or radiation, mesothelin-targeted T-cell therapy offers a novel approach by harnessing the body's immune system to attack cancer cells. This treatment works by modifying T cells to specifically target and destroy cells that express mesothelin, a protein often found in abundance on the surface of cancer cells. Researchers are excited about this therapy because it represents a targeted, potentially more precise way to combat cancer with fewer side effects compared to traditional treatments. Additionally, the ability to tailor the timing of T-cell infusion for each patient adds a personalized element to the therapy, potentially increasing its effectiveness.
What evidence suggests that this trial's treatments could be effective for metastatic HER2-negative breast cancer?
Research has shown that a new approach using specially modified T cells, which participants in this trial will receive, holds promise for treating certain types of breast cancer. In one study, these T cells proved very effective against triple-negative breast cancer, a particularly aggressive type. Another study found that about 30% of breast cancer cases have a protein called mesothelin, which these T cells target. This finding suggests that focusing on mesothelin could be a useful strategy to combat some breast cancers. While more research is needed, the early results offer hope for those with tumors containing mesothelin.12346
Who Is on the Research Team?
Shanu Modi, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment
Leukapheresis for harvesting PBMCs and administration of cyclophosphamide
Treatment
Infusion of mesothelin-targeted T cells and inpatient monitoring
Follow-up
Participants are monitored weekly as outpatients for safety and effectiveness
Long-term follow-up
Participants are monitored for long-term safety and effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- AP1903
- Cyclophosphamide
- Mesothelin-targeted T cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
United States Department of Defense
Collaborator