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Administration of Her2 Chimeric Antigen Receptor Expressing T Cells for Subjects With Advanced Sarcoma (HEROS)


Phase 1
N/A
N/A
Open (Enrolling)
Both
Sarcoma

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Trial Information

Administration of Her2 Chimeric Antigen Receptor Expressing T Cells for Subjects With Advanced Sarcoma (HEROS)


Because the cells have 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.

When the patient is enrolled on this study, they will be assigned a dose of HER2-CD28 T
cells.

The patient will be given an 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.

Each patient will be followed for 6 weeks after the T-cell infusion for evaluation of
toxicity. They will have standard tests and procedures as well as research blood draws.

If the patient has stable disease (the tumor did not grow) or there is a reduction in the
size of the tumor on imaging studies after the T-cell infusion, they can receive additional
doses of the T cells at 6 to 12 weeks intervals.

Inclusion Criteria


INCLUSION CRITERIA:

Procurement Eligibility:

1. Diagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive
osteosarcoma, not treatable by surgical resection.

2. Karnofsky/Lansky score of 50 or greater

3. Informed consent explained to, understood by and signed by patient/guardian.
Patient/guardian given copy of informed consent.

Treatment Eligibility:

1. Diagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive sarcoma,
not treatable by surgical resection and with disease progression after receiving at
least one prior systemic therapy.

2. Recovered from the acute toxic effects of all prior chemotherapy at least 4 weeks
before entering this study.

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

4. Life expectancy 6 weeks or greater

5. Karnofsky/Lansky score of 50 or greater

6. Bilirubin 3x or less, AST 5x or less, Serum creatinine 2x upper limit of normal or
less, Hgb 9.0 g/dl or greater, WBC greater than 2,000/ul, ANC greater than 1,000/ul,
platelets greater than 100,000/ul

7. Pulse oximetry of 90% or greater on room air

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

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

10. Informed consent explained to, understood by and signed by patient/guardian.
Patient/guardian given copy of informed consent

EXCLUSION CRITERIA:

At time of Procurement:

1. Known HIV positivity

At time of Treatment:

1. Severe intercurrent infection

2. Known HIV positivity

3. Pregnant or lactating

4. 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 patients with dose limiting toxicity after one injection of HER2-specific T cells

Outcome Description:

To determine the safety of one intravenous injection of autologous T cells expressing HER2-specific chimeric antigen receptor (CAR) in patients with advanced HER2-positive sarcoma.

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Nabil M Ahmed, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine/Texas Children's Hospital

Authority:

United States: Institutional Review Board

Study ID:

24489-HEROS

NCT ID:

NCT00902044

Start Date:

July 2009

Completion Date:

July 2030

Related Keywords:

  • Sarcoma
  • Refractory Sarcoma
  • Metastatic Sarcoma
  • Sarcoma
  • HER2-positive
  • Gene Therapy
  • HER2-specific T cells
  • Sarcoma

Name

Location

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