Administration of EBV Specific Cytotoxic T Lymphocytes to Recipients of Mismatched-Related or Phenotypically Similar Unrelated Donor Marrow Grafts
We will obtain blood from the donor and will first make a B cell line called a
lymphoblastoid cell line or LCL by infecting the blood with a laboratory strain of EBV
called B95. We will then 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 the normal cells and freeze them.
The marrow donor's T cells will be thawed and injected through an intravenous line for a
period of 10 minutes. The subject may be premedicated with diphenhydramine (Benadryl) and
acetaminophen (Tylenol). We would give one dose of the cells on or after day 45 following
transplant if the subject agreed and was well enough. If the EBV DNA levels remain high or
the subject has persistent disease, s/he may be eligible to receive up to 5 additional
injections of T cells at the original dose at monthly intervals. After the subject has
received the T cells, s/he will be contacted by the research nurse or another member of the
study team weekly for 6 weeks, then once every three months for a year so that we can check
on his/her progress.
We will continue to follow the subject in the BMT clinic after the injections. To learn more
about the way the T cells are working, an extra 40 mls (about 8 teaspoonfuls) of blood will
be taken pre-infusion, 4 hours after the infusion, 3-4 days post infusion (optional) and at
1, 2, 4 and 6 weeks after the T cell infusions, and then at 3, 6, 9, and 12 months post
infusion. The blood should come from the central intravenous line, and should not require
extra needle sticks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of one intravenous injection of BMT donor derived EBV specific cytotoxic T lymphocytes (CTLs) in BMT recipients at high risk.
Helen E Heslop, MD
Center for Cell and Gene Therapy, Baylor College of Medicine
United States: Food and Drug Administration
|Texas Children's Hospital||Houston, Texas|
|The Methodist Hospital||Houston, Texas 77030|