Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)

Summary

Participation Requirements

Description

Patients will give the investigators blood to make CD19 CD28 (with and without CD137) chimeric receptor-T cells in the laboratory. These cells will be grown and frozen. To make the T cells, investigators will take blood (or blood from a donor) and stimulate it with growth factors to make the T cells...

Patients will give the investigators blood to make CD19 CD28 (with and without CD137) chimeric receptor-T cells in the laboratory. These cells will be grown and frozen. To make the T cells, investigators will take blood (or blood from a donor) and stimulate it with growth factors to make the T cells grow. To get the CD19 antibody and CD28 (with or without CD137) to attach to the surface of the T cell, they will insert the antibody gene 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 to find the T cells in the blood after injecting them; in order to tell them apart investigators have made two viruses that are slightly different because one has CD137. These two viruses can be told apart by a special laboratory test. Because the patient will receive cells with a new gene in them, the patient will be followed for a total of 15 years to see if there are any long term side effects of gene transfer. If the patient cannot visit the clinic, he or she will be contacted by the research coordinator or physician. When subjects enroll on this study, they will be assigned a dose of CD19 chimeric receptor-T cells. 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/he may receive one treatment of cyclophosphamide (Cytoxan) and fludarabine if the doctor thinks this is appropriate. This drug will decrease the numbers of the subject's own T cells before infusion of the CD19 chimeric receptor T cells. If subject is already receiving chemotherapy, this may not be needed. The investigators would prefer subjects do not receive other chemotherapy until 6 weeks after cell infusion but they can do so if their doctor thinks it is medically necessary. Patients will be given an injection of cells into the vein through an IV at the assigned dose. The injection will take about 20 minutes. The investigators will follow them in the clinic after the injection for up to 3 hours. If after a 6 week evaluation period after the infusion, the patient seems to be experiencing a benefit (confirmed by radiological studies, physical exam and/or symptoms), s/he may be able to receive up to five additional doses of the T cells if s/he wishes. The first repeat infusion can only take place at least 6 weeks after the first infusion. Any additional infusions after that would be at least 4 weeks apart. All additional infusions will be at the same dose level received the first time or a lower dose. The treatment will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital.

Tracking Information