This study is for patients that have chronic lymphocytic leukemia (CLL). This research study aims to determine the safety and dosage of special cells that may make the patients own immune system fight the cancer. To do this, we will put a special gene into cancer cells that have been taken from the patients body. This will be done in the laboratory. This gene will make the cells produce interleukin 2 (IL-2), which is a natural substance that may help the immune system kill cancer cells. Additionally, we will stimulate the cancer cells with another natural protein called CD40 ligand (CD40L), which experiments in animal and human cells in vitro demonstrated can help IL-2 perform better. Some of these cells will then be put back into the patient's body. Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that combining substances like IL-2 and CD40L helps the body kill cancer cells. An experimental treatment similar to this has already been used in children and similar experimental treatments are being used in adults with other cancers.
This is a phase I trial to assess the safety of a dose escalation of hCD40L-expressing autologous tumor cells with a fixed dose of recombinant hIL-2 gene transduced autologous leukemic blasts. All eligible patients will be treated with a minimum of three and up to six injections. There will be no use of placebo or control subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
IL-2-B-CLL 2 x 10\^7; CD40L-B-CLL 0
IL-2-B-CLL 2 x 10\^7; CD40L-B-CLL 2 x 10\^6
IL-2-B-CLL 2 x 10\^7; CD40L-B-CLL 2 x 10\^7
The Methodist Hospital
Houston, Texas, United States
safety of injections of autologous malignant B cells from B-CLL patients, which have been modified to secrete hIL-2 and hCD40L.
Time frame: 12 weeks
anti-tumor immune responses
Time frame: 15 years
obtain preliminary data on the anti-tumor effects of this treatment regimen.
Time frame: 15 years
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