This early phase 1 clinical trial will test the safety and effectiveness of genetically engineered NY-ESO-1 specific (c259) T-cells cells with or without pembrolizumab (Keytruda) in treating relapsed or refractory (unresponsive to treatment) multiple myeloma.
NY-ESO-1 is a protein found on many types of cancer cells including myeloma cells. NY-ESO-1 specific T-cells are T-cells that are taken from the patient and genetically engineered to recognize the NY-ES0-1 protein. This allows the T-cells to orchestrate an immune attack against cancerous cells. Pembrolizumab is an FDA approved immunotherapy for cancer that has spread throughout the body. It uses the body’s own immune system to identify and kill cancer cells. Pembrolizumab works by inhibiting a protein on immune cells that normally dampens immune responses.
This trial will determine the safety and effectiveness of NY-ESO-1 T-cells with or without pembrolizumab. The study will examine the side effects for 3.5 years and evidence of response for up to 5 years. Time to disease progression and overall survival will also be observed.
Who are they looking for?
This study is recruiting 20 patients with secretory relapsed or refractory multiple myeloma with the HLA-A2 marker. Refractory patients who have not responded to any prior therapy should have received at least one immunomodulatory drug (immune stimulation) and proteasome inhibitor. Men and women of childbearing potential must agree to use contraception during the trial.
Patients cannot have autoimmune diseases or significant heart disease. Ideal candidates should not have received chemotherapy, anticancer vaccines, immunosuppressants, radiotherapy, or proteasome inhibitors within 2 weeks prior to entry. Patients should not have received live-virus vaccines or other investigational drugs within 4 weeks, and immunotherapy within 6 weeks prior to entry. Participants should also be out of any major surgery for 4 weeks before the start of the trial. Patients should have adequate organ function.
How will it work
Patients will be randomly divided into two groups. Group 1 will receive NY-ESO-1 T-cells, and group 2 will receive NY-ESO-1 T-cells with pembrolizumab. Initially, all patients will undergo a lab procedure to obtain T-cells on days -7, -6, and -5. On day 1 all patients will receive the NY-ESO-1 T-cells intravenously (through IV into a vein). Patients in group 2 will be given pembrolizumab intravenously on day 22.