Gene and Vaccine Therapy for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for certain advanced cancers by combining gene therapy with a vaccine. The aim is to reprogram a patient's immune cells to better target cancer cells that express a specific protein called NY-ESO-1. This approach pairs gene therapy with a vaccine to enhance the immune response following a stem cell transplant. Individuals with stage IV or locally advanced cancers that have not responded to other treatments and whose cancer cells express the NY-ESO-1 protein may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received systemic cancer treatment, including immunotherapy, within one month before starting the trial. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that a treatment using modified immune cells has been tested in previous studies and appears safe. Patients generally responded well, experiencing manageable side effects. Serious side effects, common in some cancer treatments, were rare.
Studies have also shown that dendritic cell vaccine therapy is safe. Patients did not experience serious side effects like those from chemotherapy or radiation. The vaccine helps the immune system recognize and fight cancer cells without causing significant harm to the body.
Both treatments appear well-tolerated based on prior research, offering a hopeful option for those considering participation in clinical trials.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this treatment because it uses a novel approach to target cancer cells by combining gene and vaccine therapy. Unlike traditional treatments like chemotherapy and radiation, which attack both cancerous and healthy cells, this therapy harnesses the body's own immune system. It involves engineering a patient's white blood cells with a specific retroviral vector that targets cancer cells expressing the NY-ESO-1 antigen. Additionally, the treatment includes a dendritic cell vaccine that further boosts the immune response. This targeted approach has the potential to improve effectiveness while reducing side effects, making it a promising option for patients.
What evidence suggests that this trial's treatments could be effective for cancer?
Research shows that a new treatment using modified immune cells targets a protein often found on cancer cells. Patients with various tumors have previously responded well to this treatment. In this trial, participants will receive NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL, designed to enhance the immune system's ability to combat advanced cancers.
Participants will also receive vaccines made from dendritic cells, which have shown promise in boosting the immune system's attack on cancer. Some trials reported a significant reduction in tumors, with a 31.7% overall response rate in certain cancers. These findings suggest that combining these treatments might enhance the body's ability to fight cancer.26789Who Is on the Research Team?
Antonio Ribas, MD, PhD
Principal Investigator
Jonsson Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients over 16 with advanced cancers expressing NY-ESO-1 protein, HLA-A*0201 positive, and no alternative treatments available. They must have good kidney function, be willing to undergo biopsies and leukapheresis, and not have had recent cancer treatments or immunosuppressants.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Conditioning
Patients receive cyclophosphamide and fludarabine phosphate intravenously to prepare for transplant
Transplant and Initial Treatment
Patients receive NY-ESO-1 TCR transduced autologous PBMC and NY-ESO-1 peptide pulsed dendritic cell vaccine therapy, along with aldesleukin
Extended Vaccine Therapy
Patients may receive additional doses of NY-ESO-1 peptide pulsed dendritic cell vaccine therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dendritic cell vaccine therapy
- NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor