Administration of Peripheral Blood T-Cells and EBV Specific CTLs Transduced to Express GD-2 Specific Chimeric T Cell Receptors to Patients With Neuroblastoma
Earlier, the patient gave us blood to make 14g2a chimeric receptor-T cells and 14g2a
chimeric receptor-EBV CTLs in the laboratory. These cells were grown and frozen for the
patient. The patient received treatment with these cells. However, there are enough cells
remaining that we are able to offer to treat the patient with an additional dose if they
would like.
As with the original treatment, the patient will be given an injection of cells into the
vein through and IV. Before the injection is received, the patient will be given a dose of
Benadryl and Tylenol. The injection will take about 2 minutes. We will follow the patient in
the clinic after the injection for 3 hours. The treatment will be given by the Center for
Cell and Gene Therapy at Texas Children's Hospital.
Medical tests before treatment--
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 tumor by scans and bone marrow studies if the bone marrow may show
evidence of disease
Medical tests during and after treatment:
The patient will receive standard medical tests when they are getting the infusions and
after:
- Physical exams
- Blood tests to measure blood cells, kidney and liver function
- Measurements of tumor by scans and bone marrow studies if the bone marrow had evidence
of disease 6 weeks after each infusion
Because the patient has received cells with a new gene in them the patient will be followed
for a total of 15 years to see if there are any long term side effects of gene transfer. If
they have a procedure related to their tumor (for example a biopsy or tumor resection), we
will request permission to obtain a tissue sample. This will help investigators learn more
about T cell and CTL treatment of neuroblastoma. In the event of death, we will request
permission to perform an autopsy to learn more about the effects of these infusions on the
disease.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the safety of escalating doses of 14g2a.zeta chimeric receptor transduced autologous EBV CTLs and 14g2a.zeta transduced autologous peripheral blood T-cells in pts with neuroblastoma who were lymphodepleted by CD45 monoclonal antibodies (MAbs).
15 yrs
Yes
Chrystal U Louis, MD, MPH
Principal Investigator
Baylor College of Medicine
United States: Food and Drug Administration
13149-NESTLES
NCT00085930
April 2003
December 2021
Name | Location |
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Texas Children's Hospital | Houston, Texas |