Treatment of Chronic Lymphocytic B-Leukemia (B-CLL) With Human IL-2 Gene Modified and Human CD40 Ligand-Expressing Autologous Tumor Cells
Before starting treatment some of the cancer cells will be taken from the patient and
separated in the laboratory. A specially produced human virus (adenovirus) that carries the
IL-2 gene will be put into the cells. The rest of the cancer cells will be stimulated to
express on their surface a substance called the human CD40 ligand. These substances (IL-2
and CD40L), already naturally present in the body, are meant to help the immune system fight
In this study, the modified cancer cells will be injected under the skin. There will be up
to six shots. We do not know the best amount of special cells to use, so different patients
will get different numbers of cells.
After the first three shots (if more modified cancer cells are available), patients may be
able to have three additional shots. After they have received six shots, they may be able to
have additional shots if the cancer has gotten smaller and more of the cells are available.
A complete history and physical examination is necessary before a patient can be enrolled in
the study. A physical examination will also be performed weekly for ten weeks after the
injection, then on week twelve, then monthly for one year. Patients will then have yearly
checkups for the next fifteen years. After the first and second shots, we will remove some
of the modified cells that have been injected under the skin, to study them. We will do this
by removing a section of skin (referred to as a skin biopsy) at the place where the cells
were injected. These tests will help us to see whether or not the modified cells are killing
cancer cells and whether or not the cancer cells are growing. If we suspect the cancer cells
are growing, we may repeat this procedure after the third and fourth shots.
To study how the immunity is working in the patients system, we will take blood samples
before the first injection, then weekly for 10 weeks, on week 12, once a month for a year,
and then eventually once a year for fifteen years. These blood samples must be taken at The
Methodist Hospital. The total amount of blood that will be obtained is approximately two to
three tablespoonfuls, which is considered a safe amount. If the patient has additional
injections, blood will be drawn prior to each injection. Additional office visits may be
If the patient decides to withdraw at any time during the study both samples and data
collected during the study will be maintained with identifiers for safety reasons.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of 3-6 SQ injections of autologous malignant B cells from chronic B-CLL pts, which have been modified ex vivo to secrete human interleukin-2 (hIL-2) and to express human CD40 ligand (hCD40L).
Malcolm K Brenner, MD
Center for Cell and Gene Therapy, Baylor College of Medicine
United States: Food and Drug Administration
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