Full TitleA Phase 1 Multicenter Study Evaluating the Safety and Tolerability of KTE-X19 in Adult Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
The purpose of the phase I portion of this study is to find the highest dose of CAR T-cell immunotherapy (axicabtagene ciloleucel) that can be given safely in patients with chronic lymphocytic leukemia (CLL) that persists or came back after at least two prior regimens of therapy, including ibrutinib. The purpose of the phase II portion is to assess the safety of this CAR T-cell therapy further and also see how well it works against CLL.
For patients receiving CAR T-cell therapy, some of a patient’s own T cells are removed and genetically modified in a laboratory to recognize their own cancer cells. The modified T cells, known as CAR T cells, are then returned to the patient to find and kill CLL cells throughout the body.
To prepare for CAR T-cell therapy, patients will first receive chemotherapy that is often given to people with CLL. The chemotherapy is designed to reduce the number of leukemia cells in the body, and its effects on the immune system may help the CAR T cells grow better and live longer. All treatments in this study are given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have CLL that persists or came back after at least two prior regimens of therapy, including ibrutinib.
- Patients may not have previously received treatment that targets the CD19 protein (the target of this CAR T-cell therapy).
- Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Mark B. Geyer at 212-639-3290.