An Open-label, Phase I Clinical Trial of Autologous T Cells Transduced With NY-ESO-1 Antigen-specific High-affinity T Cell Receptors in NY-ESO-1-positive Patients With Advanced Solid Tumors
This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.
• Sign informed consent before conducting any trial-related activities;
• Age of 18-75 years old, male or female;
• Patients with first-line treatment failure;
• Measurable lesions according to RECIST1.1 criteria.
• During the trial screening period, the following two screening criteria must be met (by the sponsor) :
‣ HLA-A\*02 positive;
⁃ The positive rate of NYESO-1 immunohistochemical staining was ≥20%.
• ECOG score 0-1;
• The expected survival time is more than 3 months;
• Antineoplastic drugs and treatments were not allowed for 4 weeks before TCR-T cell infusion;
• Echocardiography showed left ventricular ejection fraction ≥50%;
⁃ Laboratory test results should at least meet the following specified indicators:
∙ WBC ≥3.0×109/L;
‣ Absolute neutrophil count (ANC) ≥1.5×109/L;
‣ Absolute lymphocyte count (ALC) ≥1.0×109/L;
‣ platelet (PLT) ≥75×109/L;
‣ hemoglobin ≥10g/dL (no blood transfusion in the past 7 days);
‣ Prothrombin time or INR≤1.5x upper limit of normal unless receiving anticoagulant therapy;
‣ Partial prothrombin time (APTT) ≤1.5x upper limit of normal time, unless receiving anticoagulant therapy;
‣ 24-hour creatinine clearance ≥60mL/ min;
‣ Aspartate aminotransferase (AST/SGOT) ≤2.5×ULN;
‣ alanine aminotransferase (ALT/SGPT) ≤2.5×ULN;
‣ Total bilirubin (TBIL) ≤1.5×ULN
⁃ Negative pregnancy tests in women of childbearing potential prior to study treatment; Consent must be given to use effective contraception during treatment.
⁃ During the whole period of the trial, I can regularly visit the enrolled research institutions for relevant testing, evaluation and management.