A Phase I Trial of in Vitro Expanded Autologous Invariant Natural Killer Cells in Cancer
- 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
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the feasibility of isolating and expanding in vitro autologous iNKT cells from cancer patients for therapeutic use.
Steven Balk, MD, PhD
Beth Israel Deaconess Medical Center
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|