bone and soft tissue sarcoma
Conditions
Interventions
Single Group Assignment:NY-ESO-1(TCR Affinity Enhancing Specific T cell Therapy)
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. sign an informed consent before undertaking any trial-related activities; 2. Aged 14 to 70 years old; 3. First-line treatment failed patients with bone and soft tissue sarcoma by licensed pathologist; 4. First-line treatment failed patients; 5. with measurable lesions according to Response Evaluation Criteria In Solid Tumors1.1 or immune related response criteria standard; 6. meet the two screening indicators: HLA-A*0201+, NYESO-1+(=25% by immunohistochemisty); 7. Eastern Cooperative Oncology Group score 0-1;life expectancy is longer than 3 months; 8. The patient did not receive anti-tumor therapy within 4 weeks before enrollment; 9. A brain metastasis patient in a stable condition for one month after anti-tumor therapy can be included; 10. left ventricular ejection fraction=50%; 11. Lab test results meet the following requirements: white blood cell count=3.0×10^9/L; absolute neutrophil count=1.5 ×10^9/L (No human granulocyte colony stimulating factor support); blood platelet=75 ×10^9/L; Hemoglobin=10g/dL (No transfusion in the last 7 days); Prothrombin time or International normalized rate =1.5×normal upper limit, except taking anticoagulant therapy; thrombin time=1.5×normal upper limit, except taking anticoagulant therapy; a 24-hour creatinine clearance rate=60mL/ min; Aspartate transaminase / serum glutamic oxaloacetic transaminase=2.5 ×upper limit of normal; Alanine aminotransferase/ serum glutamate pyruvate transaminase=2.5 ×upper limit of normal; alkaline phosphatase=2.5 ×upper limit of normal; total bilirubin=1.5×upper limit of normal (expect that the subject has Gilber's syndrome); 11. no pregnant womenfemale patients must use contraceptive measures during the study and prohibit any homosexual or heterosexual; 12. The patients can regularly visit the research institutions for related tests, evaluations, and management during the study period.
Exclusion criteria
Exclusion criteria: 1. other types of tumors; 2. received major surgery, conventional chemotherapy, large-area radiotherapy, immune therapy or any biological anti-tumor therapy 4 weeks before enrollment; 3. allergic to ingredients in this trial; 4. common terminology criteria for adverse events =2 because of the previous surgery or treatment-related adverse reactions; 5. with two types of primary solid tumors; 6. poorly managed hypertension (systolic blood pressure >160 mmHg and / or diastolic blood pressure > 90 mmHg) or clinically serious (for example, active) cerebrovascular diseases such as cerebrovascular incident (within 6 months prior to signing the informed consent), myocardial infarction (within 6 months prior to signing the informed consent), unstable angina, grade II or above heart failure according to New York Heart Association Grading Congestive, or severe arrhythmia can not be controlled by medication or has a potential impact on the study; with consecutive three times of obvious abnormality on electrocardiogram or average QT corrected interval =450 millisecond; 7. combined with other serious organic and mental disorders; 8. serious or active bacteria, viral or fungal infections that require systemic treatment; 9. with autoimmune diseases: such as a history of inflammatory bowel disease or other autoimmune diseases determined by the investigator as unsuitable for the study (e.g. systemic lupus erythematosus,vasculitis, invasive pulmonary disease); 10. within 4 weeks prior the infusion, received chronic systemic steroid cortisone, hydroxyurea, immunomodulatory treatment (for example: Interleukin 2, alpha or gamma interferon, granulocyte colony stimulating factor, mammalian target of rapamycin inhibitors, cyclosporine, Thymosin etc); 11. with organ transplantation, autologous/allogeneic stem cell transplantation and renal replacement therapy; 12. with central nervous system metastasis but not receive treatment; 13. with uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or liver failure; 14. alcohol and / or drug abuse; 15. pregnant or lactating women; 16. received concomitant medication prohibited by this trial; 17. with any medical condition or disease determined by the investigators that may be detrimental to this trial; 18. without legal capacity / limited behavior.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Initial effectiveness; | — |
Countries
China
Contacts
Public ContactXing Zhang
Sun Yat-sen University Cancer Center
Outcome results
None listed