Administration of Tumor-Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes to Patients With Active or Relapsed Hodgkin or Non-Hodgkin Lymphoma
The patient will give blood to make TAA specific cytotoxic T cells in the lab. These cells
will be grown and frozen. The time from the collection of the blood to make the T cells to
when the cells are given back to the patient is about 1 to 2 months.
The cells will then be injected by IV into the patient over 10 minutes. Initially, two doses
of T cells will be given two weeks apart. The patient may be eligible to receive up to six
additional doses of the T cells at 6-8 week intervals. All of the treatments will be given
by the Center for Cell and Gene Therapy at the Methodist Hospital or Texas Children's
There are 2 stages of this study: an antigen-escalation phase and a dose-escalation stage.
The antigen-Escalation phase will be first. Patients will receive TAA-specific T cells
targeting first 1 and then 2 TAAs. Once this schedule proves safe, the next group of
patients will receive TAA-specific T cells targeting first 2 and then 3 TAAs. This process
will continue until all 4 levels are studied. This means that the final cohort of patients
will receive TAA-specific T cells targeting first 4 and then 5 TAAs. If the side effects are
too severe, the number of TAAs being targeted will be lowered or the T cell injections will
After the antigen escalation phase the dose escalation phase will begin. Patients will be
started on the lowest dose (1 of 4 different levels) of 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 4 dose levels are studies. If the side effects are too severe, the dose
will be lowered or the T cell injections will be stopped.
For both stages, patients will be followed after the injections up to one year from the last
Study Duration: Patients will be on study for approximately one year. If patients receive
additional doses of the T cells as described above, the patient will be followed until 1
year after the last dose of T-cells.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of patients with adverse events
To determine the safety of 2 intravenous injections of autologous TAA-specific cytotoxic T-lymphocytes (CTL) in patients with Hodgkin's or non-Hodgkin's lymphoma.
Catherine M Bollard, MD
Baylor College of Medicine
United States: Food and Drug Administration
|Texas Children's Hospital||Houston, Texas|
|The Methodist Hospital||Houston, Texas 77030|