Autologous EBV Specific CTLs for Therapy of Severe Chronic EBV Infection
Ten to sixty ml (2-12 teaspoons) of blood will be collected from the patient which we use to
grow the T cells. These T cells are then stimulated with EBV infected cells (which have been
treated with radiation so that they cannot grow). This stimulation trains the T cells to
kill EBV infected cells. We then test the T cells to make sure that they kill the EBV
infected cells.
Therapy can take place in one of the specifically designated outpatient clinics so hospital
admission is not required. First, patients will be given doses of Tylenol (for any
aches/pains) and Benadryl (for any minor allergic reactions such as itching/rash). Next,
the T cells will be injected into a vein over a 10 minute period. Patients will be closely
watched for any side effects.
If a patient shows some response to the treatment they may receive up to three additional T
cell injections at three month intervals. Patients will need to be seen every other week in
the clinic for six weeks after the injection. Following that, patients will either be seen
in the clinic or contacted by one of the research staff working on this study, once a month
for one year.
To learn more about the way the T cells are working and how long they last in the body, an
extra 40 mls(8 teaspoonfuls) of blood will be taken at these visits. Additionally, 3 mls
(1/2 teaspoonful) of blood will be taken prior to the infusion and monthly thereafter to
conduct a CBC (a test to look at the components of the blood).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
to determine the safety of intravenous injections of autologous EBV specific cytotoxic T cell lines in individuals with severe chronic EBV infection
1 yr
Yes
Helen E Heslop, MD
Principal Investigator
Center for Cell and Gene Therapy, Baylor College of Medicine
United States: Food and Drug Administration
H8216
NCT00058591
January 2000
December 2008
Name | Location |
---|---|
Texas Children's Hospital | Houston, Texas |
The Methodist Hospital | Houston, Texas 77030 |