Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma

Inclusion Criteria

• •Procurement Eligibility:
• •1. Diagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive osteosarcoma.
• •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 with disease progression after receiving at least one prior systemic therapy.
• •2. Recovered from acute toxic effects of all prior cytotoxic chemotherapy at least 4 weeks before entering this study. PD1/PDL1 inhibitors will be allowed to continue during treatment if medically indicated.
• •3. Normal ECHO (Left ventricular ejection fraction (LVEF) has to be within normal, institutional limits)
• •4. Life expectancy 6 weeks or greater
• •5. Karnofsky/Lansky score of 50 or greater
• •6. Bilirubin 3x or less, AST 3x or less, Serum creatinine 2x upper limit of normal or less, Hgb 7.0 g/dl or greater, WBC greater than 2,000/ul, ANC greater than 1,000/ul, platelets greater than 100,000/ul. Creatinine clearance is needed for patients with creatinine greater than 1.5 times upper limit of normal.
• •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. Chest radiograph for baseline evaluation of lungs
• •11. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent