Administration of LMP-Specific Cytotoxic T-Lymphocytes to Patients With Relapsed EBV-Positive Lymphoma (ALCI)
We will first test a biopsy of the tumor or lymph node that has already been done to see if
the tumor or tissue cells are EBV positive. If the patient is eligible, we will then take 60
of blood from the patient or their donor on one or two occasions. We will use this blood to
grow T cells. We will first grow special type of cells called dendritic cells or monocytes
which will stimulate the T cells and we will put a specially produced human viruses that
carries the LMP genes into the dendritic cells or monocytes. They will then be used to
stimulate T cells. This stimulation will train the T cells to kill cells with LMP on their
surface. We will then grow these LMP specific CTLs by more stimulation with EBV infected
cells. These EBV infected cells will be treated with radiation so they cannot grow.
Once we have made sufficient numbers of T cells we will test them to make sure they kill
cells with LMP on their surface. If the counts are low we may need to obtain additional
blood samples to make these cells.
Prior to giving the patient the CTLs we will test the cells to make sure they don't attack
The cells will then be thawed and injected into the patient over 10 minutes, after
pretreatment with Tylenol and Benadryl. Tylenol and Benadryl are given to prevent a possible
allergic reaction to the T cell administration. Initially, two doses of T cells will be
given two weeks apart. If after the second infusion there is a reduction in the size of the
lymphoma on CT or MRI scan as assessed by a radiologist, the patient can receive up to six
additional doses of the T cells if the patient wishes. This is a dose escalation study which
means that for some patients the second dose may be larger than the first. All of the
treatments will be given by the Center for Cell and Gene Therapy at Texas Children's
Hospital or the Methodist Hospital.
We will follow the patient after the injections. The patient will either be seen in the
clinic or they will be contacted by a research nurse yearly for 5 years. To learn more about
the way the T cells are working in the body, an extra 20-40 mls of blood will be taken
before each infusion and then 4 hours after each infusion(optional), 3-4 days after each
infusion (optional) and then weekly for 2 weeks after each infusion (total of 9 times). Two
weeks after the last infusion, blood will then be taken again and then every 3 months for 1
year, then once a year for 5 years. We will use this blood to see how long the T cells last
and to look at the immune response to the cancer.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of 2 intravenous injections of autologous or allogeneic LMP-specific cytotoxic T-lymphocytes (CTL) in patients with relapsed Hodgkin's or non-Hodgkin's lymphoma.
Catherine Bollard, MD
Center for Cell and Gene Therapy, Baylor College of Medicine
United States: Food and Drug Administration
|Baylor College of Medicine||Houston, Texas 77030|
|Texas Children's Hospital||Houston, Texas|
|The Methodist Hospital||Houston, Texas 77030|