Full TitleA Phase I Clinical Trial of Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients with Recurrent MUC16ecto+ Solid Tumors
The purpose of this study is to assess the safety and to find an optimal dose of an investigational therapy for women with ovarian, fallopian tube, or primary peritoneal cancer that has come back despite prior therapy. The investigational treatment involves T cells that have been genetically modified to find and attack a protein that is found on many ovarian cancer cells.
T cells are white blood cells that normally fight infection. In this study, T cells are being removed from the patient and genetically modified in the laboratory to recognize a protein on many ovarian cancer cells called MUC16. This approach is a form of immunotherapy. The T cells will also be modified to produce IL-12, a protein that may help the T cells stay longer in a patient’s body.
Not everyone who is screened will be able to get the modified T cells. In the treatment portion of this study, patients will receive the genetically modified T cells in two divided doses. Half of the T cells with be given intravenously (by vein), and a few days later, the remaining half will be given intraperitoneally (directly into the abdomen) in the hospital. Some patients in this study will also receive the anticancer drug cyclophosphamide intravenously before the T cells. The first group of patients treated on the study and the first patient at each new dose level will need to receive the T cells in the intensive care unit.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have high-grade serous ovarian, fallopian tube, or primary peritoneal cancer that has come back despite at least two but no more than five prior regimens of chemotherapy, one of which included a platinum-containing drug.
- At least 3 weeks must pass between the completion of prior treatments and entry into the study.
- At least 6 months must pass between the completion of prior immunotherapy and treatment on the study.
- Patients’ tumors must contain the MUC16 protein.
- Patients must not have a history of seizures or brain metastases
- This study is for women age 18 and older.