Phase I Clinical Trial of Human AntiCD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Lymphoid Malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia)
The purpose of this study is to determine if it is possible to treat relapsed or refractory
lymphoid malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic
Lymphocytic Leukemia) with a new type of T cell-based immunotherapy (therapy that uses the
immune system to treat the cancer).
This study seeks to determine the safety of the treatment of relapsed or refractory B cell
lymphomas, relapsed/ refractory chronic lymphocytic leukemia and relapsed/refractory acute
lymphoblastic leukemia with chimeric antigen receptor T cells targeting CD19 and to find the
recommended phase II dose for this cellular therapy.
T cells are a type of white blood cell that helps the body fight infections. This treatment
uses T cells already present within the body that have been modified outside of the body by a
lentivirus and then returned to the participant by an infusion to target the cancer.
Lentivirus is a family of viruses that can be used by scientists to alter cells, which then
could be used to change the course of a disease. This type of treatment is sometimes referred
to as adoptive cell transfer (ACT). In this study the specific type of cells that will be
used is called human chimeric antigen receptor T cells (CAR-T cells). The CAR-T cells that
will be reinfused to the body are modified using a lentivirus that is no longer active. The
CAR-T cells will be returned to the body through an intravenous (IV) infusion. Another
purpose of this study is to learn about the side effects and toxicities related to this
treatment. Human CAR-T cell therapy is investigational (experimental) and works by removing T
cells from the blood and modifying them to be able to target the cancer.
Non Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia
Fully human anti CD19 CAR-T Cell Dose
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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