Combination Immunotherapy Targeting Sarcomas

Korábbi kezelés

• The patient is receiving therapy of other new drugs and under evaluation;
• Patients who need immunosuppressive drugs;
• Receiving systemic corticosteroid 2 weeks before enrollment except for inhaled steroids;
• Previous treatment with any gene therapy;
• Patients previously experienced toxicity from cyclophosphamide and doxorubicin;

Más betegség

• The disease is progressing rapidly;
• Epilepsy history or other CNS diseases;
• Uncontrolled active infection;
• Active hepatitis B virus, hepatitis C virus or HIV infection;
• Patients who have other uncontrolled diseases such as obstruction of lung function would preclude participation as outlined;
• In condition that may bring risks to subjects or interference to clinical trials.

Laborértékek

• History of long QT syndrome or severe heart diseases;
• Creatinine\>2.5mg/dl or ALT/AST\>3 times normal or bilirubin\>2.0 mg/dl;

Egyéb

• Evidence of tumor potentially causing airway obstruction;
• Pregnant or lactating women;
• Patients who have CNS sarcoma;

• Stage Ⅲ，Ⅳ sarcoma patients or recurrent sarcoma patients;
• Age: ≥ 6 months and ≤80 years of age at the time of enrollment;
• At least 2 weeks since the last standard chemotherapy or radiotherapy and immunosuppressive therapy such as steroid hormone before enrollment;
• Side effects of chemotherapy have been well managed;
• Confirmed malignant cell expression of CART target antigens by IHC or flow
• Karnofsky /jansky score of 50% or greater;
• Expected survival \> 8 weeks;
• ANC≥ 1×10\^6/L，PLT ≥ 1×10\^8/L;
• Pulse oximetry of≥90% on room air；
• Adequate hepatic function, defined as aspartate aminotransferase(AST)\< 5 times upper limit of normal(ULN),serum bilirubin \< 3 times ULN;
• Adequate renal function, defined as serum creatinine less than 2 times ULN, if serum creatinine more than 1.5 times ULN, creatinine clearance rate test is needed;
• Patients must have sufficient autologous CART cells at does greater than 0.5x10\^6 cells/kg body weight;
• Sign an informed consent and assent.