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Administration of HER2 Chimeric Antigen Receptor Expressing CMV-Specific Cytotoxic T Cells Ins Patients With Glioblastoma Multiforme (HERT-GBM)


Phase 1
N/A
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme (GBM)

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Trial Information

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.

Inclusion Criteria


INCLUSION CRITERIA:

- Histopathological verification of glioblastoma multiforme (GBM: WHO grade IV) with
recurrent or progressive disease after front line therapy.

- HER2 positive GBM

- CMV seropositive

- Normal ECHO (Left ventricular ejection fraction (LVEF) has to be with in normal,
institutional limits)

- Life expectancy 6 weeks or greater

- Karnofsky/Lansky score 50 or greater

- Patient or parent/guardian capable of providing informed consent

- Bilirubin 3x or less than normal, AST 5x or less than normal, creatinine 2x normal or
less for age and Hgb 9.0 g/dl or more; WBC greater than 2,000/ul; ANC greater than
1,000/ul; platelets greater than 100,000/ul

- Pulse oximetry 90% or more on room air

- Sexually active patients must be willing to utilize one of the more effective birth
control methods for 6 months after the CTL infusion. The male partner should use a
condom.

- Available autologous HER2.CAR-transduced CMV-specific cytotoxic T lymphocytes with
15% or greater expression of HER2.CAR determined by flow-cytometry and killing of
HER2-positive targets 20% or more in cytotoxicity assay.

- Recovered from the acute toxic effects of all prior chemotherapy at least 4 weeks
before entering this study. One exception is Temozolomide(TMZ), an alkylation agent
used as a radiosensitizer and adjuvant chemotherapeutic agent for GBM. Due to the
extremely short half life of TMZ, patients will be allowed to continue receiving it
up to two days prior to cell infusion and cannot restart until six weeks after the
infusion.

EXCLUSION CRITERIA:

- Severe intercurrent infection

- Known HIV positivity

- Pregnant or lactating

- History of hypersensitivity reactions to murine protein-containing products

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of subjects with dose limiting toxicity after CTL infusion

Outcome Description:

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.

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Nabil Ahmed, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine/Texas Children's Hospital

Authority:

United States: Institutional Review Board

Study ID:

H-24487 - HERT GBM

NCT ID:

NCT01109095

Start Date:

October 2010

Completion Date:

October 2031

Related Keywords:

  • Glioblastoma Multiforme (GBM)
  • Glioblastoma Multiforme (GBM)
  • HER2
  • CMV
  • Brain Cancer
  • Autologous HER2.CAR CMV-specific cytotoxic CTL
  • CMV-specific cytotoxic CTL
  • Glioblastoma

Name

Location

Texas Children's HospitalHouston, Texas  
The Methodist HospitalHouston, Texas  77030