NCT00631072

In Vitro Expanded Autologous Invariant Natural Killer Cells in Cancer

A Phase I Trial of in Vitro Expanded Autologous Invariant Natural Killer Cells in Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine whether we can purify and grow a population of cells from the participants blood (iNKT cells) and then safely give them back to the participant in increased numbers, and whether these cells will then stimulate the bodies own immune response against the cancer. These iNKT cells have been used in laboratory studies and information from these and other research studies suggest that increasing the number of these cells in the blood can stimulate the immune response against tumors.

Detailed description

* The first step in the study will be to collect iNKT cells from the participants peripheral blood. For this procedure an intravenous catheter will be used to remove the blood. The white blood cells will be removed from the blood and the red blood cells and plasma will be returned to the participant (leukopheresis). * We will then purify the iNKT cells from these collected white blood cells, and will grow them in culture plates in the lab under strictly controlled sterile conditions. This can take 4-6 weeks. * If we are successful in growing the iNKT cells to large enough numbers, they will be divided into 3 equal doses. Participants will receive one dose of these cells by intravenous infusion every 2 weeks or days 1, 15 and 29. A blood sample will be taken immediately before each infusion, and at 1 and 4 hours after each infusion. Participants will be asked to return for blood samples on day 2, 3, 4 and 8 after infusion. * The initial group of 3-6 participants will not receive any other therapy with the iNKT cell infusions. However, the subsequent group of 6 patients will in addition receive GM-CSF, which can further stimulate the immune system and may increase the effects of the iNKT cells. This medication is administered by subcutaneous injection and will be given daily for 10 days beginning the day of the second and third infusion. * Participants will be on this research study for about 14 weeks, which includes the time for the cell purification and culture, treatment, and follow-up observation.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	INKT	Administered in 3 equal doses by intravenous infusion on days 1, 15 and 29.
DRUG	GM-CSF	Given subcutaneously once daily for 10 days beginning the second day of the second and third infusion

Timeline

• Start date: 2008-02-01
• Primary completion: 2014-08-01
• Completion: 2015-04-01
• First posted: 2008-03-07
• Last updated: 2017-06-09

Locations

2 sites across 1 country: United States