soft tissue sarcoma
Conditions
Interventions
TAEST16001 cells :TAEST16001 cells treat tumor antigen NY-ESO-1
Sponsors
Sun Yat-Sen University Cancer center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The informed consent form (ICF) (genotype and tumor antigen screening and primary screening) should be signed before any research related operation; 2. Aged >= 18 years and = 20%; 7. ECOG score 0-1 and expected survival time > 3 months; 8. Color Doppler echocardiography indicates left ventricular ejection fraction >= 50%; 9. Laboratory test results should at least meet the following criteria: - White blood cell count >= 3.0 x 10^9 / L - Absolute neutrophil count (ANC) >=1.5 x 10^9 / L (without the support of G-CSF and GM-CSF, at least 14 days before CLT); - Absolute lymphocyte count (ALC) >= 0.7 x 10^9 / L; - Platelet (PLT) >= 75 x 10^9 / L (no transfusion treatment 14 days before CLT); - Hemoglobin >= 10g / dl (no transfusion treatment 14 days before CLT); - Prothrombin time international INR = 60ml / min; - AST / SGOT <= 2.5 x ULN; - ALT / SGPT <= 2.5 x ULN; - TBIL <= 1.5×ULN 10. Women of childbearing age who have not undergone sterilization before menopause must agree to use effective contraceptive measures within one year from the beginning of study treatment (chemotherapy for clearing lymph nodes) to the end of cell transfusion, and the serum pregnancy test is negative within 14 days before the first cell transfusion. 11. Men who have not undergone sterilization must agree to use effective contraceptive measures from the beginning of the study treatment (chemotherapy) until one year after the last cell transfusion.
Exclusion criteria
Exclusion criteria: 1. The last dose of anti-tumor therapy (chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization or traditional Chinese medicine / Chinese herbal medicine with anti-tumor indications) was received within 4 weeks before cell reinfusion; 2. The live attenuated vaccine had been inoculated within 4 weeks before cell reinfusion; 3. The patients with bone metastasis in the whole body; 4. It is known that any component used in the treatment of this study will produce allergy Response; 5. Not recovered from previous operation or treatment-related adverse reactions to 160mmhg and / or diastolic blood pressure > 90mmHg) or with clinical significance Cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (within 6 months prior to signing the master informed consent), myocardial infarction (within 6 months prior to signing the master informed consent), unstable angina pectoris, congestive heart failure with NYHA grade II or above, or serious arrhythmia that cannot be controlled by drugs or has potential impact on research and treatment Results of ECG showed clinically significant abnormality or average QTCF >= 450ms; 8. Combined with other serious organic or mental diseases; 9. Suffering from systemic active infection requiring treatment, including but not limited to active tuberculosis, known HIV positive patients or clinical active hepatitis A, B and C Patients with inflammation, including virus carriers, should be excluded; 10. Patients with autoimmune diseases: those with inflammatory bowel disease history and those with autoimmune disease history determined by the researchers as unsuitable for this study, such as systemic lupus erythematosus, vasculitis, and invasive lung disease, should be excluded (except vitiligo subjects); 11. Those with cell transfusion within 4 weeks before and during the study should be used (if there is a long-term plan) Use) systemic sterols, hydroxyurea, immunomodulators (e.g., interferon a or ?, GM-CSF, mTOR inhibitors, cyclosporin, thymosin, etc.); 12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy; 13. Diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or liver failure that are not known to be controlled; 14. Alcohol and / or drug abusers; 15. Pregnant or lactating women; 16. Subjects with any coexisting medical conditions or diseases that may affect the development of this study determined by the investigator; 17. Subjects without legal capacity / limited capacity of behavior; 18. Patients who have received similar gene therapy products within 4 weeks before cell reinfusion and are not suitable for inclusion by evaluation; 19. Patients judged by the investigator are difficult to complete the research party All visits or procedures required by the case (including the follow-up period), or insufficient compliance to participate in the study, or the patients considered unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximun tolerated dose;dose limited toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax Peak of TAEST16001 cells in peripheral blood; | — |
Countries
China
Contacts
Public ContactXing Zhang
Sun Yat-Sen University Cancer Center
Outcome results
None listed