{
    "info": {
        "nct_id": "NCT06196294",
        "official_title": "GPC3/Mesothelin Targeted CAR-γδT for Immunotherapy of Solid Cancer: Phase I Clinical Trial",
        "inclusion_criteria": "1. Patients with advanced cancer that expresses GPC3 or Mesothelin protein; 2. Life expectancy >12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available autologous transduced T cells with greater than or equal to 20% expression of GPC3/Mesothelin-CAR determined by flow-cytometry and killing of Mesothelin-positive targets greater than or equal to 20% in cytotoxicity assay; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.\n\n-\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Had accepted gene therapy before;\n2. Severe virus infection such as HBV, HCV, HIV, et al;\n3. Known HIV positivity;\n4. Active infectious disease related to bacteria, virus,fungi,et al;\n5. Other severe diseases that the investigators consider not appropriate;\n6. Pregnant or lactating women;\n7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);\n8. Other conditions that the investigators consider not appropriate. -",
        "miscellaneous_criteria": ""
    },
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                "line": "Healthy volunteers allowed",
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                    {
                        "exact_snippets": "Healthy volunteers allowed",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
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                        "exact_snippets": "Healthy volunteers allowed",
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                        }
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        },
        {
            "identified_line": {
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                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
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                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
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                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
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                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "maximum age of 75 Years",
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                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "-",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Had accepted gene therapy before;",
                "criterions": [
                    {
                        "exact_snippets": "Had accepted gene therapy before",
                        "criterion": "gene therapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    "exact_snippets": "Had accepted gene therapy before",
                    "criterion": "gene therapy",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Known HIV positivity;",
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                    {
                        "exact_snippets": "Known HIV positivity",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "positivity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Known HIV positivity",
                    "criterion": "HIV status",
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                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Other severe diseases that the investigators consider not appropriate;",
                "criterions": [
                    {
                        "exact_snippets": "Other severe diseases",
                        "criterion": "severe diseases",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Other severe diseases",
                                "criterion": "severe diseases",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "the investigators consider not appropriate",
                                "criterion": "investigator's consideration",
                                "requirement": {
                                    "requirement_type": "appropriateness",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Pregnant or lactating women;",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating women",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating women",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);",
                "criterions": [
                    {
                        "exact_snippets": "Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)",
                        "criterion": "systemic steroid treatment",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.5,
                                "unit": "mg prednisone equivalent/kg/day"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)",
                        "criterion": "systemic steroid treatment",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.5,
                                "unit": "mg prednisone equivalent/kg/day"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Other conditions that the investigators consider not appropriate. -",
                "criterions": [
                    {
                        "exact_snippets": "Other conditions that the investigators consider not appropriate.",
                        "criterion": "other conditions",
                        "requirement": {
                            "requirement_type": "appropriateness",
                            "expected_value": "considered appropriate by investigators"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Other conditions that the investigators consider not appropriate.",
                    "criterion": "other conditions",
                    "requirement": {
                        "requirement_type": "appropriateness",
                        "expected_value": "considered appropriate by investigators"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Active infectious disease related to bacteria, virus,fungi,et al;",
                "criterions": [
                    {
                        "exact_snippets": "Active infectious disease related to bacteria, virus, fungi, et al",
                        "criterion": "infectious disease",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Active infectious disease related to bacteria, virus, fungi, et al",
                        "criterion": "infectious disease",
                        "requirement": {
                            "requirement_type": "cause",
                            "expected_value": [
                                "bacteria",
                                "virus",
                                "fungi"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Active infectious disease related to bacteria, virus, fungi, et al",
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                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Active infectious disease related to bacteria, virus, fungi, et al",
                        "criterion": "infectious disease",
                        "requirement": {
                            "requirement_type": "cause",
                            "expected_value": [
                                "bacteria",
                                "virus",
                                "fungi"
                            ]
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "1. Patients with advanced cancer that expresses GPC3 or Mesothelin protein; 2. Life expectancy >12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available autologous transduced T cells with greater than or equal to 20% expression of GPC3/Mesothelin-CAR determined by flow-cytometry and killing of Mesothelin-positive targets greater than or equal to 20% in cytotoxicity assay; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "advanced cancer that expresses GPC3 or Mesothelin protein",
                        "criterion": "cancer expression",
                        "requirement": {
                            "requirement_type": "protein",
                            "expected_value": [
                                "GPC3",
                                "Mesothelin"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Life expectancy >12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate heart, lung, liver, kidney, and blood function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": [
                                "heart",
                                "lung",
                                "liver",
                                "kidney",
                                "blood"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Available autologous transduced T cells with greater than or equal to 20% expression of GPC3/Mesothelin-CAR determined by flow-cytometry",
                        "criterion": "autologous transduced T cells",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Available autologous transduced T cells with greater than or equal to 20% expression of GPC3/Mesothelin-CAR determined by flow-cytometry",
                        "criterion": "autologous transduced T cells",
                        "requirement": {
                            "requirement_type": "expression",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Available autologous transduced T cells with greater than or equal to 20% expression of GPC3/Mesothelin-CAR determined by flow-cytometry",
                        "criterion": "autologous transduced T cells",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "flow-cytometry"
                        }
                    },
                    {
                        "exact_snippets": "killing of Mesothelin-positive targets greater than or equal to 20% in cytotoxicity assay",
                        "criterion": "cytotoxicity assay",
                        "requirement": {
                            "requirement_type": "killing efficiency",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Informed consent explained to, understood by and signed by patient/guardian",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "explained, understood, and signed"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "2. Severe virus infection such as HBV, HCV, HIV, et al;",
                "criterions": [
                    {
                        "exact_snippets": "Severe virus infection such as HBV, HCV, HIV",
                        "criterion": "virus infection",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Severe virus infection such as HBV, HCV, HIV",
                        "criterion": "virus infection",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "HBV",
                                "HCV",
                                "HIV"
                            ]
                        }
                    }
                ]
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Severe virus infection such as HBV, HCV, HIV",
                                "criterion": "virus infection",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "Severe virus infection such as HBV, HCV, HIV",
                                "criterion": "virus infection",
                                "requirement": {
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                                    "expected_value": "HBV"
                                }
                            }
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                            {
                                "exact_snippets": "Severe virus infection such as HBV, HCV, HIV",
                                "criterion": "virus infection",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "Severe virus infection such as HBV, HCV, HIV",
                                "criterion": "virus infection",
                                "requirement": {
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                                    "expected_value": "HCV"
                                }
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                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Severe virus infection such as HBV, HCV, HIV",
                                "criterion": "virus infection",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "Severe virus infection such as HBV, HCV, HIV",
                                "criterion": "virus infection",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "HIV"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}