Pilot Study for Patients With Chemotherapy Resistant or Refractory CD19 Leukemia and Lymphoma

  • STATUS
    Recruiting
  • participants needed
    10
  • sponsor
    University of Pennsylvania
Updated on 7 November 2020
cancer
lymphoma
leukemia
tumor cells

Summary

This is a study for people who have been previously treated for Leukemia/Lymphoma. In particular, it is a study for people who have a type of Leukemia/Lymphoma that involves B cells (a type of white cell), which contain the cancer. This is a new approach for treatment of Leukemia/Lymphoma that involves B cells (tumor cells). This study will take the subject's white blood cells (T cells) and modify them in order to target the cancer. The subject's T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). Both ways of modifying the cells tells the T cells to go to the B cells (tumor cells) and turn "on" and potentially kill the B cells (tumor cells). The modification is a genetic change to the T cells, or gene transfer, in order to allow the modified T cells to recognize your tumor cells but not other normal cells in the subject's body. These modified cells are called CART-19 T cells. The two types of CART-19 T cells will be given back to subject's through an infusion. In addition to determining the safety of this approach, the purpose of the study is to determine which way of modifying the T cells works better in turning them "on" to fight cancer. This is done by monitoring levels of both types of modified cells in the subject's blood stream, and if possible, in the bone marrow and tumor tissue for four weeks after the infusion. It is expected that one type of modified cell will grow better than the other in the subject's blood. However, it is possible that there will be no difference between the two types of cells. All subjects who receive CART19 T cells will be enrolled in a Long Term Follow up study to monitor subjects. Subjects will be followed every 6 months for five years following the 1st infusion of the T cells. If the CART19 T cells are no longer found in the blood after five years, then subjects will be contacted yearly for the next 10 years. If the CART19 T cells are found in the blood at five years after the 1st infusion of T cells, then the subjects will continue to be seen once a year until the CART19 T cells are no longer found in the blood for a maximum of 15 years.

Description

This is an open label, single center, pilot study to evaluate the safety and tolerability, and differential persistence and engraftment of autologous T cells engineered to express a chimeric antigen receptor targeting CD19 which is linked either to the CD3 or CD3:4-1BB signaling chains in a competitive repopulation setting in patients with chemotherapy-resistant or - refractory CD19+ leukemia or lymphoma. Upon enrollment, patients will undergo leukapheresis (10L) and an optional bone marrow +/- lymph node biopsy approximately four weeks prior to dosing. T cells will be isolated from the leukapheresis by elutriation, split and genetically modified in parallel by a lentiviral vector expressing one of the two chimeric antigen receptors, and then the cells will be expanded in parallel. Between dosing and treatment, patients may undergo an additional chemotherapy treatment depending upon their disease. At dosing, patients will receive a mixture of the redirected autologous T cells against CD19 (CART-19 cells), which were produced in parallel. Twenty minutes after dosing, blood samples will be taken to serve as a baseline control for the ratio between the cells with either vector. Patients will be monitored weekly for four weeks. At the end of four weeks, patients will undergo a second leukapheresis (2L) and second optional bone marrow +/- lymph node biopsy. At this point, the patient will also undergo restaging. The change in the ratio of the vector transduced cells to each other between baseline and week four will be evaluated. Observation and monitoring of patients will continue on a monthly basis until week 24 post dosing. Annual follow-up for lentiviral vector safety will be carried out for 15 years in accordance with FDA guidelines for retroviral vectors. Ten subjects will be targeted for this study, with an expected rate of drop out of 30% due to disease progression between enrollment and week four post dosing.

Details
Condition Acute Lymphocytic Leukemia, Follicular Lymphoma, Chronic Lymphocytic Leukemia (CLL), Mantle Cell Lymphoma, Prolymphocytic Leukemia, Large Cell Lymphoma
Treatment CART-19
Clinical Study IdentifierNCT00891215
SponsorUniversity of Pennsylvania
Last Modified on7 November 2020

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