Engineered immune cells take on sarcoma in early trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 EXCLUSION CRITERIA: At time of Procurement: 1. Known HIV positivity 2. Severe previous toxicity from cyclophosphamide or fludarabine 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 5. Severe previous toxicity from cyclophosphamide or fludarabine