Phase II Study of TAEST16001 in Soft Tissue Sarcoma

Exclusion Criteria

• •Received the last leukocyte apheresis within 4 weeks. Anti-tumor therapy (chemotherapy, endocrine therapy, targeted therapy, tumor embolization or traditional Chinese medicine with anti-tumor indications, etc.); immunotherapy within 1 month before the signing of the main informed consent;
• •4 days before cell infusion received live attenuated vaccine within 1 week;
• •Patients with ≥3 bone metastases;
• •Known to have allergic reactions to any components used in the treatment of this study;
• •No previous surgery or treatment-related adverse reactions recovered to \<Grade 2 CTCAE v5.0;
• •Patients with a history of meningeal metastasis or central nervous system metastasis, or patients with clear underlying diseases of the central nervous system within 6 months before cell reinfusion, and left significant symptoms;
• •Uncontrolled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>90 mmHg) or clinically significant (eg active) cardiovascular and cerebrovascular diseases, such as cerebrovascular accident within 1 month), myocardial infarction (within 6 months before signing the main informed consent), unstable angina, congestive heart failure with New York Heart Association (NYHA) class II or above, or severe arrhythmia that cannot be treated with drugs Control or have potential impact on study treatment; ECG results show clinically significant abnormality or average QTcF ≥ 450 ms in 3 consecutive times (at least 5 minutes between each time) (see Appendix 2 for the formula);
• •Combined with other serious devices;
• •Patients with systemic active infections that require treatment, including but not limited to active tuberculosis, known HIV-positive patients or clinically active hepatitis A, B, and C patients, including virus carriers;
• •Patients with autoimmune diseases: those with a history of inflammatory bowel disease and a history of autoimmune diseases judged by the investigator to be unsuitable for this study, such as systemic lupus erythematosus, vasculitis, and infiltrative lung disease, should be excluded ( (except for vitiligo and psoriasis that do not require systemic immunosuppressive therapy);
• •G-CSF or GM-CSF has been used within 2 weeks before leukapheresis, or within 4 weeks before cell reinfusion and planned to be used during the study period (If there is long-term use) systemic cortisone steroids, hydroxyurea, immunomodulatory drugs (eg: alpha or gamma interferon, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.);
• •Organ isotypes History of transplantation, allogeneic stem cell transplantation and renal replacement therapy;
• •Known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure;
• •Known alcohol and/or drug abuser;
• •Pregnant or lactating women;
• •Suffering from any co-existing medical conditions or diseases that the investigators determined may affect the conduct of this trial.
• •Subjects with no legal capacity/restricted capacity;
• •Previously received treatment targeting NY-ESO-1, or received cellular immunotherapy within 12 months before cell reinfusion, investigator Patients deemed unsuitable for enrollment;
• •Received immunotherapy (immune checkpoint blockade therapy: such as PD-1, PD-L1 antibody treatment, etc.) within 3 months before cell reinfusion;
• •Patients judged by the investigator Difficulty completing all visits or procedures (including follow-up periods) required by the study protocol, or insufficient compliance to participate in this study; or patients deemed unsuitable for inclusion by the investigator.