NCT00078520

Treatment of B-CLL With Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia
• Leukemia, B-Cell, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	Dose Level 1	IL-2-B-CLL 2 x 10\^7; CD40L-B-CLL 0
BIOLOGICAL	Dose Level 2	IL-2-B-CLL 2 x 10\^7; CD40L-B-CLL 2 x 10\^6
BIOLOGICAL	Dose Level 2- Fixed Dose	IL-2-B-CLL 2 x 10\^7; CD40L-B-CLL 2 x 10\^7

Timeline

• Start date: 2003-01-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2004-03-02
• Last updated: 2020-01-21

Locations

1 site across 1 country: United States