CHRONIC LYMPHOCYTIC B-LEUKEMIA Clinical Trial
Official title:
Treatment of Chronic Lymphocytic B-Leukemia (B-CLL) With Human IL-2 Gene Modified and Human CD40 Ligand-Expressing Autologous Tumor Cells After Depletion of Regulatory T Cells
In the laboratory, we will put a special gene into cancer cells that have been taken from
the subject. This gene will make the cells produce interleukin 2 (IL-2), which may help the
patient's immune system kill cancer cells. Also, we will use CD40 ligand (CD40L) with the
IL-2. Studies of cancers in animals and in cancer cells that are grown in laboratories have
suggested adding the CD40L helps the IL-2 work better. Some of these new cells will then be
given back to the subject as a vaccine shot.
We believe that a part of the subject's immune system (cells called T-reg cells) might try
to kill off these special cells. If the T-reg cells do that, the vaccine would not work as
well or last as long. To try to avoid this, before the special cells are put back into the
subject's body, we will give them an intravenous (IV) dose of IL-2 immunotoxin (called
denileuk diftitox or ONTAK). ONTAK should get rid of some of the T-reg cells in the
subject's body which should help the special cells work better and longer.
The purpose of this study is to learn the safety and cancer-fighting effects of using IL-2
with the vaccine.
This is a phase I trial to assess the safety of depleting regulatory T (Treg) cells using
1-3 doses of an interleukin-2 immunotoxin directed to the CD25 antigen (denileukin diftitox,
ONTAK) in chronic lymphocytic leukemia (B-CLL) patients, followed by six subcutaneous (SC)
injections of autologous leukemic cells modified ex vivo to secrete human interleukin-2
(hIL-2) and to express human CD40 ligand (hCD40L). Patients will receive a fixed dose (2 x
10e7) of IL-2 secreting B-cells together with 2 x 10e7 hCD40L expressing B-cells,
representing a safe, well tolerated and immunogenic dose in our previous dose escalation
study.
All eligible patients will be treated with six injections. Any patient whose disease
regresses after the administration of 6 injections may be offered further injections of
tumor vaccine if sufficient vaccine is available. There will be no use of placebo or control
subjects.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00058786 -
Treatment of Chronic Lymphocytic B-Leukemia With IL-2 and CD-40 Autologous Tumor Cells
|
Phase 1 |