{
    "info": {
        "nct_id": "NCT03960060",
        "official_title": "Evaluation of CAR (Chimeric Antigen Receptor) Modified Autologous T Cell CCT301-59 in Patients With Recurrent or Refractory Solid Tumors on the Basis of Safety, Tolerability and Anti-tumor Activity Study.",
        "inclusion_criteria": "1. Voluntary to participate in the clinical study, subjects and their family members agree to sign the informed consent form and follow all trial procedures.\n2. Male or female subjects 18-70 years of age.\n3. Subjects are diagnosed as recurrent or refractory solid tumors (soft tissue sarcoma, gastric cancer, pancreatic cancer and bladder cancer) with identified unresectable advanced or metastatic tumors by radiology and histology or cytology, progression after the first line or above treatment, or intolerance to standard treatment.\n4. At least one measurable lesion in accordance with RECIST 1.1, the long diameter of non-lymph node lesions ≥10mm (millimeter) according to CT (computerized tomography) scan-sectional image, or the short diameter of lymph node lesions ≥15mm; the longest axis of the measurable lesion ≥10 mm in CT scan (CT scan layer ≤ 5mm); FDG PET (fluorodeoxyglucose -positron emission tomography) of the measurable lesion > 3 SUV (standardized uptake values).\n5. Subjects with ROR2 positive tumor tissue: the percentage of ROR2 positive staining cells in tumor cells detected by immunohistochemistry or RNA (Ribonucleic acid) in situ hybridization is ≥ 50%. The samples could be used within one year , otherwise the sample will be re-collected for biopsy.\n6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 to 1.\n7. Expected survival will be ≥ 12 weeks.\n8. The organ and hematopoietic functions must meet the following requirements:\n\n   * Hemoglobin (HGB)≥90 g/L (gram per litre), no blood transfusion within two weeks;\n   * White blood cell count (WBC) ≥ 2.5×10^9/L;\n   * Absolute neutrophil count (ANC) ≥ 1.5×10^9/L;\n   * Platelet count (PLT) ≥ 80×10^9/L;\n   * Total bilirubin (TBIL) ≤ 3.0ng/dL or ≤ 5 ULN (Upper Limit of Normal);\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; AST and ALT≤ 5×ULN in case the abnormal hepatic function is caused by hepatocellular carcinoma or liver metastasis from other tumors;\n   * Serum creatinine (Cr) ≤ 1.5×ULN; or creatinine clearance (CrCl) ≥ 50 mL/min (milliliter per minute);\n9. Prothrombin time (PT): INR (International Normalized Ratio) <1.7 or prolonged, PT prolonged < 4 seconds from normal level;\n10. Normal neurologic evaluation;\n11. Sufficient venous access for venous intravenous blood collection and infusion, no other contraindications for blood cell separation;\n12. Able to receive treatment and follow-up, including the treatment at the enrolled site;\n13. Female subjects of childbearing age must take acceptable measures to minimize the possibility of pregnancy during the trial. The serum or urine pregnancy test must be negative prior to pre-treatment for female subjects of childbearing age;\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "1. Pregnant or breastfeeding female subjects;\n2. Active infection of hepatitis B, or active hepatitis C;\n3. Infection with HIV/AIDS (Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome);\n4. Other active infection with clinical significance;\n5. Previous diseases or concurrent diseases:\n\n   Subjects diagnosed as serious autoimmune disease in long-term (over two months) requirement of systemic immunosuppressant (steroid), or as immune mediated symptomatic diseases including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (e.g., Wegener's granulomatosis);\n6. Subjects with previous diagnosis as motor neuron disease;\n7. Subjects with previous disease of toxic epidermal necrolysis;\n8. Having any mental disorder that may affect the understanding of informed consent and relevant questionnaires, including dementia, altered mental status;\n9. Having serious uncontrollable disease judged in the study that may affect the subjects receiving the study treatment;\n10. Subjects with other active malignant tumors in the past five years including basal or squamous cell skin cancer, superficial bladder cancer or in situ breast cancer who have been completely cured, and without any follow-up treatment are not included;\n11. Current using of systemic steroid or steroid inhalant;\n12. Have used of immunotherapy treatment in the past three months or PD-1 (Programmed cell death protein 1) antibody, PD-L1 (Programmed death-ligand 1) antibody, PD-L2 antibody, CD137 (tumor necrosis factor receptor superfamily member 9, 4-1BB) antibody or CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) antibody, or cell therapy.\n13. Allergy to immunotherapy or relevant medications;\n14. Meningeal metastasis or central nervous system metastasis in the last 6 months, with obvious underlying diseases of the central nervous system, and leaving obvious symptoms;\n15. Subjects with NYHA (New York Heart Association) heart failure grade ≥ 2 or uncontrollable hypertension by standard treatment and requiring special treatment, or with history of myocarditis, or occurrence of myocardial infarction within one year;\n16. Previous organ transplantation or be ready for organ transplantation;\n17. Pancreatic cancer with pancreatitis;\n18. Active bleeding;\n19. Subjects with pleural effusion or abdominal effusion that require clinical treatment or intervention;\n20. Being judged by investigators as inappropriate to participate in this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Voluntary to participate in the clinical study, subjects and their family members agree to sign the informed consent form and follow all trial procedures.",
            "criterions": [
                {
                    "exact_snippets": "Voluntary to participate in the clinical study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects and their family members agree to sign the informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "follow all trial procedures",
                    "criterion": "compliance with trial procedures",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Male or female subjects 18-70 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Male or female subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "18-70 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Subjects are diagnosed as recurrent or refractory solid tumors (soft tissue sarcoma, gastric cancer, pancreatic cancer and bladder cancer) with identified unresectable advanced or metastatic tumors by radiology and histology or cytology, progression after the first line or above treatment, or intolerance to standard treatment.",
            "criterions": [
                {
                    "exact_snippets": "diagnosed as recurrent or refractory solid tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "recurrent",
                                "refractory"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "soft tissue sarcoma, gastric cancer, pancreatic cancer and bladder cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "soft tissue sarcoma",
                                "gastric cancer",
                                "pancreatic cancer",
                                "bladder cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "identified unresectable advanced or metastatic tumors by radiology and histology or cytology",
                    "criterion": "tumor resectability and stage",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": "unresectable"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "progression after the first line or above treatment",
                    "criterion": "treatment progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "after the first line or above treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerance to standard treatment",
                    "criterion": "treatment intolerance",
                    "requirements": [
                        {
                            "requirement_type": "intolerance",
                            "expected_value": "standard treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. At least one measurable lesion in accordance with RECIST 1.1, the long diameter of non-lymph node lesions ≥10mm (millimeter) according to CT (computerized tomography) scan-sectional image, or the short diameter of lymph node lesions ≥15mm; the longest axis of the measurable lesion ≥10 mm in CT scan (CT scan layer ≤ 5mm); FDG PET (fluorodeoxyglucose -positron emission tomography) of the measurable lesion > 3 SUV (standardized uptake values).",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "long diameter of non-lymph node lesions ≥10mm",
                    "criterion": "long diameter of non-lymph node lesions",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "short diameter of lymph node lesions ≥15mm",
                    "criterion": "short diameter of lymph node lesions",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "longest axis of the measurable lesion ≥10 mm",
                    "criterion": "longest axis of the measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "CT scan layer ≤ 5mm",
                    "criterion": "CT scan layer",
                    "requirements": [
                        {
                            "requirement_type": "thickness",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "FDG PET ... measurable lesion > 3 SUV",
                    "criterion": "FDG PET of the measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "standardized uptake value",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "SUV"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Subjects with ROR2 positive tumor tissue: the percentage of ROR2 positive staining cells in tumor cells detected by immunohistochemistry or RNA (Ribonucleic acid) in situ hybridization is ≥ 50%. The samples could be used within one year , otherwise the sample will be re-collected for biopsy.",
            "criterions": [
                {
                    "exact_snippets": "ROR2 positive tumor tissue",
                    "criterion": "ROR2 positive tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "percentage of ROR2 positive staining cells in tumor cells ... is ≥ 50%",
                    "criterion": "percentage of ROR2 positive staining cells",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "samples could be used within one year",
                    "criterion": "sample usability",
                    "requirements": [
                        {
                            "requirement_type": "time since collection",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 to 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 to 1.",
                    "criterion": "ECOG PS score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Expected survival will be ≥ 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Expected survival will be ≥ 12 weeks.",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. The organ and hematopoietic functions must meet the following requirements:",
            "criterions": [
                {
                    "exact_snippets": "organ and hematopoietic functions",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "must meet the following requirements"
                        }
                    ]
                },
                {
                    "exact_snippets": "organ and hematopoietic functions",
                    "criterion": "hematopoietic function",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "must meet the following requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin (HGB)≥90 g/L (gram per litre), no blood transfusion within two weeks;",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin (HGB)≥90 g/L",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no blood transfusion within two weeks",
                    "criterion": "blood transfusion",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* White blood cell count (WBC) ≥ 2.5×10^9/L;",
            "criterions": [
                {
                    "exact_snippets": "White blood cell count (WBC) ≥ 2.5×10^9/L",
                    "criterion": "white blood cell count (WBC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) ≥ 1.5×10^9/L;",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5×10^9/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count (PLT) ≥ 80×10^9/L;",
            "criterions": [
                {
                    "exact_snippets": "Platelet count (PLT) ≥ 80×10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin (TBIL) ≤ 3.0ng/dL or ≤ 5 ULN (Upper Limit of Normal);",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin (TBIL) ≤ 3.0ng/dL or ≤ 5 ULN (Upper Limit of Normal)",
                    "criterion": "total bilirubin (TBIL)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3.0,
                                        "unit": "ng/dL"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; AST and ALT≤ 5×ULN in case the abnormal hepatic function is caused by hepatocellular carcinoma or liver metastasis from other tumors;",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ... ≤ 2.5×ULN",
                    "criterion": "aspartate aminotransferase (AST) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "×ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) ≤ 2.5×ULN",
                    "criterion": "alanine aminotransferase (ALT) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "×ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT≤ 5×ULN ... abnormal hepatic function is caused by hepatocellular carcinoma or liver metastasis",
                    "criterion": "AST and ALT levels in case of hepatocellular carcinoma or liver metastasis",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "×ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine (Cr) ≤ 1.5×ULN; or creatinine clearance (CrCl) ≥ 50 mL/min (milliliter per minute);",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine (Cr) ≤ 1.5×ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance (CrCl) ≥ 50 mL/min (milliliter per minute)",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Prothrombin time (PT): INR (International Normalized Ratio) <1.7 or prolonged, PT prolonged < 4 seconds from normal level;",
            "criterions": [
                {
                    "exact_snippets": "Prothrombin time (PT): INR (International Normalized Ratio) <1.7",
                    "criterion": "INR (International Normalized Ratio)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.7,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PT prolonged < 4 seconds from normal level",
                    "criterion": "PT (Prothrombin Time) prolongation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "seconds"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Normal neurologic evaluation;",
            "criterions": [
                {
                    "exact_snippets": "Normal neurologic evaluation",
                    "criterion": "neurologic evaluation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Sufficient venous access for venous intravenous blood collection and infusion, no other contraindications for blood cell separation;",
            "criterions": [
                {
                    "exact_snippets": "Sufficient venous access for venous intravenous blood collection and infusion",
                    "criterion": "venous access",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no other contraindications for blood cell separation",
                    "criterion": "contraindications for blood cell separation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Able to receive treatment and follow-up, including the treatment at the enrolled site;",
            "criterions": [
                {
                    "exact_snippets": "Able to receive treatment",
                    "criterion": "ability to receive treatment",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "follow-up",
                    "criterion": "ability to follow-up",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment at the enrolled site",
                    "criterion": "ability to receive treatment at the enrolled site",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Female subjects of childbearing age must take acceptable measures to minimize the possibility of pregnancy during the trial. The serum or urine pregnancy test must be negative prior to pre-treatment for female subjects of childbearing age;",
            "criterions": [
                {
                    "exact_snippets": "Female subjects of childbearing age",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing age"
                        }
                    ]
                },
                {
                    "exact_snippets": "must take acceptable measures to minimize the possibility of pregnancy during the trial",
                    "criterion": "pregnancy prevention measures",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The serum or urine pregnancy test must be negative prior to pre-treatment",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Pregnant or breastfeeding female subjects;",
            "criterions": [
                {
                    "exact_snippets": "Pregnant ... female subjects",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding female subjects",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Active infection of hepatitis B, or active hepatitis C;",
            "criterions": [
                {
                    "exact_snippets": "Active infection of hepatitis B",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis C",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Infection with HIV/AIDS (Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome);",
            "criterions": [
                {
                    "exact_snippets": "Infection with HIV/AIDS (Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome)",
                    "criterion": "HIV/AIDS infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Other active infection with clinical significance;",
            "criterions": [
                {
                    "exact_snippets": "Other active infection with clinical significance",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Previous diseases or concurrent diseases:",
            "criterions": [
                {
                    "exact_snippets": "Previous diseases",
                    "criterion": "previous diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concurrent diseases",
                    "criterion": "concurrent diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Subjects diagnosed as serious autoimmune disease in long-term (over two months) requirement of systemic immunosuppressant (steroid), or as immune mediated symptomatic diseases including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (e.g., Wegener's granulomatosis);",
            "criterions": [
                {
                    "exact_snippets": "diagnosed as serious autoimmune disease",
                    "criterion": "serious autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "long-term (over two months) requirement of systemic immunosuppressant (steroid)",
                    "criterion": "systemic immunosuppressant requirement",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed as ... immune mediated symptomatic diseases including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (e.g., Wegener's granulomatosis)",
                    "criterion": "immune mediated symptomatic diseases",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "ulcerative colitis",
                                "Crohn's disease",
                                "rheumatoid arthritis",
                                "systemic lupus erythematosus (SLE)",
                                "autoimmune vasculitis (e.g., Wegener's granulomatosis)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subjects with previous diagnosis as motor neuron disease;",
            "criterions": [
                {
                    "exact_snippets": "previous diagnosis as motor neuron disease",
                    "criterion": "motor neuron disease",
                    "requirements": [
                        {
                            "requirement_type": "previous diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Subjects with previous disease of toxic epidermal necrolysis;",
            "criterions": [
                {
                    "exact_snippets": "previous disease of toxic epidermal necrolysis",
                    "criterion": "toxic epidermal necrolysis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Having any mental disorder that may affect the understanding of informed consent and relevant questionnaires, including dementia, altered mental status;",
            "criterions": [
                {
                    "exact_snippets": "Having any mental disorder",
                    "criterion": "mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "dementia",
                    "criterion": "dementia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "altered mental status",
                    "criterion": "altered mental status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Having serious uncontrollable disease judged in the study that may affect the subjects receiving the study treatment;",
            "criterions": [
                {
                    "exact_snippets": "serious uncontrollable disease",
                    "criterion": "disease control",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "controllability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Subjects with other active malignant tumors in the past five years including basal or squamous cell skin cancer, superficial bladder cancer or in situ breast cancer who have been completely cured, and without any follow-up treatment are not included;",
            "criterions": [
                {
                    "exact_snippets": "other active malignant tumors in the past five years",
                    "criterion": "active malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "basal or squamous cell skin cancer",
                    "criterion": "basal or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "superficial bladder cancer",
                    "criterion": "superficial bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ breast cancer",
                    "criterion": "in situ breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Current using of systemic steroid or steroid inhalant;",
            "criterions": [
                {
                    "exact_snippets": "Current using of systemic steroid",
                    "criterion": "systemic steroid use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "steroid inhalant",
                    "criterion": "steroid inhalant use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Have used of immunotherapy treatment in the past three months or PD-1 (Programmed cell death protein 1) antibody, PD-L1 (Programmed death-ligand 1) antibody, PD-L2 antibody, CD137 (tumor necrosis factor receptor superfamily member 9, 4-1BB) antibody or CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) antibody, or cell therapy.",
            "criterions": [
                {
                    "exact_snippets": "Have used of immunotherapy treatment in the past three months",
                    "criterion": "immunotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PD-1 (Programmed cell death protein 1) antibody",
                    "criterion": "PD-1 antibody",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PD-L1 (Programmed death-ligand 1) antibody",
                    "criterion": "PD-L1 antibody",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PD-L2 antibody",
                    "criterion": "PD-L2 antibody",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CD137 (tumor necrosis factor receptor superfamily member 9, 4-1BB) antibody",
                    "criterion": "CD137 antibody",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) antibody",
                    "criterion": "CTLA-4 antibody",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cell therapy",
                    "criterion": "cell therapy",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Allergy to immunotherapy or relevant medications;",
            "criterions": [
                {
                    "exact_snippets": "Allergy to immunotherapy",
                    "criterion": "allergy to immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergy to ... relevant medications",
                    "criterion": "allergy to relevant medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Meningeal metastasis or central nervous system metastasis in the last 6 months, with obvious underlying diseases of the central nervous system, and leaving obvious symptoms;",
            "criterions": [
                {
                    "exact_snippets": "Meningeal metastasis",
                    "criterion": "meningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the last 6 months",
                    "criterion": "time since metastasis",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "obvious underlying diseases of the central nervous system",
                    "criterion": "underlying diseases of the central nervous system",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "obvious"
                        }
                    ]
                },
                {
                    "exact_snippets": "leaving obvious symptoms",
                    "criterion": "symptoms",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "obvious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Subjects with NYHA (New York Heart Association) heart failure grade ≥ 2 or uncontrollable hypertension by standard treatment and requiring special treatment, or with history of myocarditis, or occurrence of myocardial infarction within one year;",
            "criterions": [
                {
                    "exact_snippets": "NYHA (New York Heart Association) heart failure grade ≥ 2",
                    "criterion": "NYHA heart failure grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable hypertension by standard treatment and requiring special treatment",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "requiring special treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of myocarditis",
                    "criterion": "myocarditis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "occurrence of myocardial infarction within one year",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Previous organ transplantation or be ready for organ transplantation;",
            "criterions": [
                {
                    "exact_snippets": "Previous organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "be ready for organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "readiness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Pancreatic cancer with pancreatitis;",
            "criterions": [
                {
                    "exact_snippets": "Pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pancreatitis",
                    "criterion": "pancreatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Active bleeding;",
            "criterions": [
                {
                    "exact_snippets": "Active bleeding",
                    "criterion": "bleeding",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Subjects with pleural effusion or abdominal effusion that require clinical treatment or intervention;",
            "criterions": [
                {
                    "exact_snippets": "pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "require clinical treatment or intervention"
                        }
                    ]
                },
                {
                    "exact_snippets": "abdominal effusion",
                    "criterion": "abdominal effusion",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "require clinical treatment or intervention"
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Being judged by investigators as inappropriate to participate in this study.",
            "criterions": [
                {
                    "exact_snippets": "Being judged by investigators as inappropriate to participate in this study",
                    "criterion": "appropriateness for study participation",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "appropriate"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}