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