Administration of Rapidly Generated LMP, BARF1 And EBNA1 Specific Cytotoxic T-Lymphocytes To Patients With EBV-Positive Lymphoma
Earlier subjects gave blood for us to make LMP/BARF1/EBNA-1 (GRALE) CTLs in the lab. These
cells were grown and frozen for the subject.
The GRALE T cells will then be thawed and injected into the subject over 2-10 minutes. The
subject may be pretreated with Tylenol and Benadryl. These are given to prevent a possible
allergic reaction to the GRALE T cell administration. Initially, two doses of GRALE T cells
will be given 2 weeks apart.
Patients will be started on the lowest dose (1 of 3 different levels) of GRALE T cells. Once
that dose schedule proves safe, the next group of patients will be started at a higher dose.
This process will continue until all 3 dose levels are studied. If the side effects are too
severe, the dose will be lowered or the GRALE T cell injections will be stopped.
If after the 2nd infusion there is a reduction in the size of the lymphoma on CT or MRI scan
as assessed by a radiologist, the subject can receive additional doses of the GRALE T cells
if they wish (up to 6 times). Follow up testing will be collected just as it had from the
1st infusion. CT scans, MRI, or nuclear imaging will be collected 1-3 months after the final
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 subjects after the injections. They will either be seen in the clinic or
the subject 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 20-50 mls (4-10 teaspoons) of blood
will be taken before each infusion and then at 2,4 and 6 weeks and 3,6,9 and 12 months after
each infusion (8 times). The blood may be drawn from the central line at the time of the
regular blood tests. We will use this blood to see how long the GRALE T cells last and to
look at the immune response to the subjects cancer.
One additional blood sample might be drawn 3 to 4 days after the infusion. Please let the
doctor know if it will be difficult to come in for this blood draw on Day 3 to 4.
Subjects will be on study for approximately 5 years. If they receive additional doses of the
GRALE T cells as described above, they will be followed until 5 years after the last dose of
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of toxicity of escalating doses of LMP, BARF1 and EBNA1 CTLs
To determine the safety of escalating doses of 2 intravenous injections of autologous rapid LMP, BARF1 and EBNA1 specific cytotoxic T-lymphocytes (CTL) in patients with EBV-associated Hodgkin's Disease or non-Hodgkin's lymphoma or T/NK-lymphoproliferative disease and CAEBV.
Helen E Heslop, MD
United States: Food and Drug Administration
|Texas Children's Hospital||Houston, Texas|
|The Methodist Hospital||Houston, Texas 77030|