T-Cell Therapy + Vaccine + Pepinemab/Trastuzumab for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or radiotherapy within 14 days before starting the trial, and you cannot be on other investigational agents within 14 days or 5 half-lives before starting the trial.
What data supports the effectiveness of the T-Cell Therapy + Vaccine + Pepinemab/Trastuzumab treatment for breast cancer?
Research shows that combining dendritic cell vaccines with trastuzumab (a drug targeting HER2) can enhance the immune response against HER2-positive breast cancer, leading to decreased tumor markers and increased survival in some patients. Additionally, dendritic cell vaccines have been shown to stimulate immune cells to attack cancer cells, suggesting potential benefits in treating early breast cancer.12345
Is the combination of T-Cell Therapy, Vaccine, and Pepinemab/Trastuzumab safe for humans?
The combination of dendritic cell vaccines and trastuzumab has been shown to be safe in clinical trials for breast cancer, with most patients tolerating the treatment well and only one patient removed due to toxicity. The treatment induced immune responses in many patients, suggesting it is generally safe for human use.23678
How is the T-Cell Therapy + Vaccine + Pepinemab/Trastuzumab treatment for breast cancer different from other treatments?
This treatment is unique because it combines a dendritic cell vaccine, which helps the immune system recognize cancer cells, with T-cell therapy and trastuzumab, a drug that targets HER2-positive breast cancer. The combination aims to enhance the immune response against cancer by increasing the effectiveness of T-cells and antibodies, potentially leading to better outcomes than using trastuzumab alone.34579
What is the purpose of this trial?
The purpose of this study is to test the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) study vaccine given in combination with pepinemab added to standard of care therapy, trastuzumab to help people with HER2 positive breast cancer.
Research Team
HEATHER HAN, MD
Principal Investigator
Moffitt Cancer Center
Eligibility Criteria
This trial is for adults with HER2 positive breast cancer who have seen their disease progress while on trastuzumab and have had no more than three lines of chemotherapy for metastatic cancer. They must be in good health otherwise, not pregnant or nursing, without a history of certain viruses (HIV, Hepatitis B/C), autoimmune diseases, or recent vaccines.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 6 weekly injections of dendritic cell (DC1) vaccines in combination with trastuzumab and pepinemab
T-Cell Therapy
Blood is collected for T-cell therapy, and patients are treated with IL-15 Expanded HER2 specific CD4+ Th1 cells
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dendritic Cell (DC1) Vaccine
- Pepinemab
- T-Cell therapy
- Trastuzumab
Dendritic Cell (DC1) Vaccine is already approved in United States for the following indications:
- Metastatic castration-resistant prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Vaccinex Inc.
Industry Sponsor