Phase I Study Of CD19 Chimeric Receptor Expressing T Lymphocytes In B-Cell Non Hodgkin's Lymphoma, Acute Lymphocytic Leukemia, and Chronic Lymphocytic Leukemia
Patients will give us blood to make CD19 CD28 chimeric receptor-T cells in the laboratory.
These cells will be grown and frozen for the patient. To make the T cells investigators take
the blood and stimulate it 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, they 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 us find the T
cells in the blood after they inject them using a special laboratory test. Because the
patients will receive cells with a new gene in them they 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, they may be contacted by the research coordinator or physician.
When the patients enroll on this study, they will be assigned a dose of CD19 CD28 chimeric
The investigators' studies so far have shown that the infused T cells may need to receive an
extra boost in order to expand efficiently in the body. Therefore, 2 weeks after T cell
infusion, the patient will receive one injection of a drug called ipilimumab, which they
believe will help the T cells grow. This drug is approved by the FDA to treat certain
cancers, such as melanoma, but the dose of drug used for this study will be lower than those
used in those other treatments to avoid side effects.
Patients will be given an injection of cells into the vein through an IV at the assigned
dose. The injection will take about 10 minutes. Patients will be followed in the clinic
after the injection for up to 3 hours. If after a 4-6 week evaluation period after the
infusion, the patient seems to be experiencing a benefit (confirmed by radiological studies,
physical exam and/or symptoms), they may be able to receive up to three additional doses of
the T cells if they wish. These additional infusions would be at least 4-6 weeks apart and
at the same dose level they 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 The Methodist
To learn more about the way the CD19 CD28 chimeric receptor-T cells are working and how long
they last in the body, extra blood will be drawn.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adverse Event Data per Patient
Evaluate the safety of autologous T-lymphocytes genetically modified to express CAR targeting CD19CAR in patients with refractory/relapsed NHL, ALL or B-CLL.
Carlos Ramos, MD
Baylor College of Medicine
United States: Food and Drug Administration
|Methodist Hospital||Houston, Texas 77030|
|Texas Children's Hospital||Houston, Texas|