Administration of Autologous Neomycin Resistant Gene Marked EBV Specific Cytotoxic T-Lymphocytes as Therapy for Patients Receiving Autologous Bone Marrow Transplant for Relapsed EBV-Positive Lymphoma.
We will take 60-70 ml (12 teaspoonfuls) of blood from the subject. We will first make a B
cell line called a lymphoblastoid cell line or LCL by infecting the subjects blood with a
laboratory strain of EBV called B95. We will then use use this EBV infected cell line (which
have been treated with radiation so that they cannot grow) as stimulator cells and mix it
with more blood. This stimulation will train the T cells to kill EBV infected cells and
result in the growth of an EBV specific T cell line. We will then test the T cells to make
sure that they kill the EBV infected cells and not your normal cells and freeze them.
The cells will be thawed and injected into subjects over 10 minutes, after pretreatment with
Tylenol and Benadryl. A total of two doses will be given two weeks apart. All of the
treatments will be given at Texas Children's Hospital or The Methodist Hospital.
We will follow subjects in the clinic after the injections. At each visit about 10ml (2
teaspoonfuls) of blood will be taken every other week for 6 weeks after the injection and
then every 3 months for 1 year to monitor the subjects blood chemistry and hematology.
To learn more about the way the T cells are working in the subjects body, an extra 40mls (8
teaspoons) of blood will be taken pre-infusion, 3-4 days post infusion (optional) and at 1,
2, 4 and 6 weeks post-infusion and then at 3, 6, 9, and 12 months. The blood may be drawn
from the subjects central line at the time of their regular blood tests.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
determine the safety of 2 IV injections of autologously derived EBV specific cytotoxic T-lymphocytes
The two injections will be given at day 0 and day 14. Three patients will be enrolled at the first dose level and followed for six weeks after the second dose (which will constitute a course) for evaluation of any critical toxicity.
Catherine Bollard, MD
Baylor College of Medicine
United States: Food and Drug Administration
|Texas Children's Hospital||Houston, Texas|
|The Methodist Hospital||Houston, Texas 77030|