TAEST16001 in Patients With Soft Tissue Sarcoma With Positive NY-ESO-1 Expression (Genotype: HLA-A*02:01): an Multi-center, Open-label and Single Arm Phase II Study
The main purpose of this trial is to evaluate the efficacy and safety of TAEST16001 cells in the treatment of advanced soft tissue sarcoma patients with HLA-A\*02:01 tissue genotype and positive tumor antigen NY-ESO-1 expression.
• Before any research-related operations, they should sign the informed consent Consent Form (ICF) (Genotype and Tumor Antigen Screening and Primary Screening);
• Age ≥18 years, and ≤70 years;
• His/cytology confirmed, unresectable or metastatic soft tissue sarcoma;
• The current stage is the failure of standard treatment (disease progression or recurrence or intolerance, such as chemotherapy, radiotherapy, targeted therapy, etc.) or lack of effective treatment methods, specifically: In addition to acinar soft tissue sarcoma and for pathological subtypes other than epithelioid sarcoma, at least adriamycin or doxorubicin combined with ifosfamide standard chemotherapy regimen should fail or not tolerate chemotherapy; For acinar soft tissue sarcoma and epithelioid sarcoma, need failure or intolerance of previous targeted drugs \[anti-angiogenesis such as Anlotinib, pazopanib, etc.\]; Note: Treatment failure refers to disease progression or inability during treatment or within 3 months of the last treatment Tolerable; disease progression in patients with neoadjuvant or adjuvant therapy \> 6 months after the end of treatment can be considered first-line therapy;
• At least 1 measurable lesion (according to RECIST1.1 criteria \[see Appendix 4 for details\]);
• Genotype and tumor antigen screening must meet the following 2 criteria: HLA-A\*02:01 positive; NY-ESO-1\* positive: immunohistochemical staining positive cells are ≥20%;
• ECOG score of 0-1 and expected survival period of more than 3 months;
• Echocardiography showed left ventricular ejection fraction ≥ 50%;
• Laboratory test results should at least meet the following specified indicators: White blood cell count ≥ 3.0×109 /L; Absolute neutrophil count (ANC) ≥ 1.5×109/L (without G-CSF and GM-CSF support, at least 14 days before lymphadenectomy); Absolute lymphocyte count (ALC) ≥ 0.7× 109/L; Platelet (PLT) ≥ 75×109/L (no blood transfusion therapy 14 days before lymphadenectomy chemotherapy); hemoglobin ≥ 9 g/dL (no blood transfusion therapy 14 days before lymphoid clearing chemotherapy); Coagulation International Normalized Ratio (INR) ≤ 1.5×ULN unless anticoagulant therapy;Partial prothrombin time (APTT) ≤ 1.5×ULN unless anticoagulant therapy; Serum creatinine ≤ 1.5 mg /dL (or 132.6 μmol/L); Creatinine clearance ≥60 mL/min; Aspartate aminotransferase (AST/SGOT)≤2.5×ULN; Alanine aminotransferase (ALT/SGPT)≤2.5×ULN; Total bile red Prime (TBIL)≤1.5×U LN; Note: If patients with liver metastases or patients with primary liver tumor lesions, aspartate aminotransferase and alanine aminotransferase should be ≤5× ULN;
• Females of childbearing age who have not received sterilization before menopause must agree to be removed from the study treatment (clearing). effective contraceptive measures should be used from the beginning of the last cell infusion to one year after the last cell infusion, and the serum pregnancy test was negative within 14 days before the first cell infusion; ) and up to one year after the last cell infusion, use effective contraception.