Treatment of Chronic Lymphocytic B-Leukemia (B-CLL) With Human IL-2 Gene Modified and Human CD40 Ligand-Expressing Autologous Tumor Cells (CLIMAT)

NCT00058786 Phase 1 COMPLETED

This is a research study 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 patient. 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 preclinical human and animal studies suggest will help IL-2 perform better. Some of these cells will then be put back into the body. The cells are grown with normal embryonic fibroblasts. 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. The purpose of this study is to learn the side effects and the safest effective dose of these special cells on the disease

Details

Lead sponsor	Baylor College of Medicine
Phase	Phase 1
Status	COMPLETED
Enrolment	9
Start date	2002-12
Completion	2010-03

Conditions

• Chronic Lymphocytic B-Leukemia

Interventions

• Injection of IL-2-secreting CD40L-expressing autologous B-CLL cells

Primary outcomes

• 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). — 3 mths

Countries

United States