Activated T Lymphocytes Expressing CARs, Relapsed CD19+ Malignancies Post-Allo HSCT(CARPASCIO)

Description

The subject or his/her donor will give blood to make CD19/CD28 chimeric receptor-T cells in the laboratory. These cells will be grown and frozen. To make the T cells, the donor/subject’s blood will be stimulated with growth factors to make the T cells grow. To get the CD19 antibody with CD28 to attach to the surface of the T cell, an antibody gene will be inserted into the T cell. This is done with a virus called a retrovirus that has been made for this study and will carry the antibody gene into the T cell. This virus also helps investigators find the T cells in the blood using a special laboratory test. Subjects will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.

When a subject enrolls on this study, s/he will be assigned a dose of CD19/CD28 chimeric receptor-T cells and should not receive other cancer treatment until 6 weeks after cell infusion.

Several studies suggest that the infused T cells need room to be able to proliferate and accomplish their functions and that this may not happen if there are too many other T cells in circulation. Because of that, if the subject’s level of circulating T cells is relatively high, s/hemay receive treatment with cyclophosphamide (Cytoxan) and fludarabine (chemotherapy drugs) before the T cells. If the subject is already receiving chemotherapy, this may not be needed.

The subject will be given an injection of cells into the vein through an IV at the assigned dose. The injection will take up to 10 minutes. The research staff will follow the subject in the clinic after the injection for up to 4 hours. If after a 4-6 week evaluation period after the infusion, the subject seems to be experiencing a benefit (confirmed by radiological studies, physical exam and/or symptoms), s/he may be able to receive up to 5 additional doses of the T cells. These additional infusions would be at least 4-6 weeks apart and at the same dose level received the first time or a lower dose.

There will be medical tests during and after treatment. To learn more about the way the CD19 chimeric receptor-T cells are working and how long they last in the body, extra blood will be drawn.