Phase I Study Of The Administration Of Peripheral Activated T-Cells and EBV Specific CTLs Expressing CD19 Chimeric Receptors For Advanced B-Cell Non-Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia (ATECRAB)
The patient or their donor will give us blood to make CD19-CD28 chimeric receptor T cells
and CD19 chimeric-EBV specific T cells in the laboratory. These cells are grown and frozen
for the patient. Because the patient will have received cells with a new gene in them they
will be followed for a total of 15 years to see if there are any long term side effects of
The patient will be assigned a dose of CD19-CD28 chimeric receptor-T cells and CD19 chimeric
receptor-EBV specific T cells. Several studies suggest that the infused T cells need room to
be able to proliferate and accomplish their functions and that this may not happen if there
are too many other T cells in circulation. Because of that, if the patient's level of
circulating T cells is relatively high, they will receive one treatment of cyclophosphamide.
This drug will decrease the numbers of the patient's own T cells before we infuse the CD19
chimeric receptor T cells. Although we do not expect any effect on your tumor with the dose
that you will receive, this drug is part of many regimens that are used to treat lymphoma or
CLL. If you are already receiving chemotherapy, thi smay not be needed.
The patient will be given an injection of cells into the vein through an IV line at the
assigned dose. The patient will be followed in the clinic after the injection for up to 3
hours. If after a 4-6 week evaluation period after the infusion, the patient seems to be
experiencing a benefit (confirmed by radiological studies, physical exam and/or symptoms),
they may be able to receive up to three additional doses of the T cells. These additional
infusions would be at least 4-6 weeks apart and at the same dose level the patietn received
the first time.
Before being treated, the patient will receive a series of standard medical tests: Physical
exam, Blood tests to measure blood cells, kidney and liver function Measurements of the
tumor by scans and/or bone marrow studies
Medical tests during and after treatment:
The patient will receive standard medical tests when they are getting the infusions and
after: Physicalexams, Blood tests to measure blood cells, kidney and liver function,
Measurements of the tumor by scans and/or bone marrow studies 6 weeks after the infusion
To learn more about the way the CD19-CD28 chimeric receptor T cells and CD19 chimeric
receptor-EBV specific T cells are working and how long they last in the body, extra blood
will be drawn at the following timepoints: On the day of the infusion blood will be taken
before the cells are given and several hours afterwards. Other blood will be drawn one week
after the infusion, 2 weeks, 4 weeks and 6 weeks after the infusion, every 3 months for 1
year, every 6 months for 4 years, then yearly for a total of 15 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate safety of escalating doses of autologous or syngeneic peripheral blood T cells and EBV-specific cytotoxic CTLs, both genetically modified to express artificial T-cell receptors targeting the CD19 molecule.
Carlos Ramos, MD
Baylor College of Medicine
United States: Food and Drug Administration
|Texas Children's Hospital||Houston, Texas|
|The Methodist Hospital||Houston, Texas 77030|