Administration of HER2 Chimeric Antigen Receptor Expressing CMV-Specific Cytotoxic T Cells Ins Patients With Glioblastoma Multiforme (HERT-GBM)
When the patient enrolls on this study, they will be assigned to a dose of HER2-CAR CMV-T
cells.
The patient will be given a single injection of cells into the vein through an IV line at
the assigned dose. The injection will take between 1 and 10 minutes. The patient will be
followed in the clinic after the injection for 1 to 4 hours. If later the subject seems to
be experiencing a benefit (confirmed by radiological studies, physical exam and/or
symptoms), s/he may be able to receive up to six additional doses of the T cells if they
wish. These additional infusions would be at least 6 to 12 weeks apart and at the same dose
level received the first time.
Medical tests before treatment--
Before being treated, the patient will receive a series of standard medical tests as
follows: Physical exam, Blood tests to measure blood cells, kidney and liver function,
Routine heart function tests (Echocardiogram),Measurements of the tumor by routine imaging
studies
Medical tests during and after treatment--
The patient will receive standard medical tests when getting the infusions and
after:Physical exams, Blood tests to measure blood cells, kidney and liver function, Routine
heart function tests (Echocardiogram) at 6 weeks after the infusion, Measurements of the
tumor by routine imaging studies 6 weeks after the infusion
To learn more about the way the HER2-CAR CMV-T cells are working and how long they last in
the body, blood will be taken on the day of the T-cell infusion, before, 1 hour and 4 hours
after the T-cell infusion, 1, 2, 4 and 6 weeks after the T-cell infusion and every 3 months
for 1 year, every 6 months for 4 years, then yearly for a total of 15 years.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of subjects with dose limiting toxicity after CTL infusion
To evaluate the safety of escalating doses of autologous CMV-specific cytotoxic T-lymphocytes (CTL) genetically modified to express chimeric antigen receptors (CAR) targeting the HER2 molecule in patients with HER2-positive Glioblastoma multiforme (GBM: WHO grade IV), who have recurrent or progressive disease after front line therapy.
6 weeks
Yes
Nabil Ahmed, MD
Principal Investigator
Baylor College of Medicine/Texas Children's Hospital
United States: Institutional Review Board
H-24487 - HERT GBM
NCT01109095
October 2010
October 2031
Name | Location |
---|---|
Texas Children's Hospital | Houston, Texas |
The Methodist Hospital | Houston, Texas 77030 |