| Eligibility |
Inclusion Criteria:
1. Sign an informed consent before undertaking any trial-related activities;
2. Aged 14 to 70 years old;
3. Patients withbone and soft tissue sarcoma in stage IV by licensed pathologist;
4. First-line treatment failed advanced patients.
5. With measurable lesions, the product of the two maximum vertical diameters should not
be less than 5mm*5mm
6. Meet the two screening indicators: HLA-A*0201+, NYESO-1+(=25% by
immunohistochemistry);
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); absolute lymphocyte count=0.7×10^9/L;blood platelet=75 ×10^9/L;
Hemoglobin=10g/dL (No transfusion in the last 14 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;
Serum creatinine: 1.5mg /dL (or 132.6 microns /L);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; total bilirubin=1.5×upper limit of normal.
In the case of liver metastasis, glutamate transaminase and glutamate alanine
transaminase should be less than 5 x ULN
12. Women of child-bearing age who have not undergone sterilization before menopause must
agree to use effective contraceptive measures at least 30 days from the start of the
study treatment to the last drug use, and serum pregnancy test is negative 14 days
before the first treatment.
13. Men who have not received sterilization must agree to use effective contraception from
the start of the study until at least 90 days after the last study medication is
administered.
14. During the whole test period, the subjects can regularly go to the enrolled research
institutions for relevant detection, evaluation and management.
Exclusion Criteria:
1. other types of tumors; If the patient has a previous history of malignant tumor, the
disease-free time of the patient needs > for 5 years.
2. received major surgery, conventional chemotherapy, large-area radiotherapy, immune
therapy or any biological anti-tumor therapy within 4 weeks before enrollment;
3. allergic to ingredients in this trial;
4. common terminology criteria for adverse events not return to under 2 level from
previous surgery or treatment-related adverse reactions;
5. 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;
6. combined with other serious organic and mental disorders;
7. serious or active bacteria, viral or fungal infections that require systemic
treatment;
8. 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);
9. 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);
10. with organ transplantation, autologous/allogeneic stem cell transplantation and renal
replacement therapy;
11. with uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung
disease, or liver failure;
12. alcohol and / or drug abuse;
13. pregnant or lactating women;
14. with any medical condition or disease determined by the investigators that may be
detrimental to this trial;
15. without legal capacity / limited behavior.
16. receive any other gene therapy products before study
|
