{
    "info": {
        "nct_id": "NCT03927573",
        "official_title": "A Multicenter, Open-label, Dose-escalating, Phase I Trial With GEM3PSCA, a PSCA Targeted Bispecific Antibody Engaging T-cells, in Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSCA Marker",
        "inclusion_criteria": "1. Male or female patients, ≥ 18 years of age\n2. Progressive PSCA positive cancer (urogenital tract (renal, transitional cell, prostate), non-small cell lung) refractory to standard treatments and with no other available standard or curative treatment\n3. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n5. Life expectancy of at least 2 months\n6. Platelets > 50,000/µl\n7. Hemoglobin > 9 g/dl\n8. Adequate renal and hepatic laboratory assessments\n9. Adequate pulmonary function with oxygen saturation (SpO2) ≥ 90 % and no structural pulmonary disease which might jeopardize patient safety according to judgement of the investigator\n10. Left ventricular ejection fraction (LVEF) of ≥ 45 %\n11. Existing port-system or central venous catheter resp. acceptance of implantation of a device\n12. A female of childbearing potential may be enrolled providing she has a negative pregnancy test at screening visit and is routinely using a highly effective method of birth control resulting in a low failure rate (e.g. hormonal contraception, intrauterine device, total sexual abstinence or sterilization) until 3 months from the last study drug administration. Male patients must also practice a highly effective method of birth Control\n13. Able to give written informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Other malignancy requiring active therapy\n2. Non-measurable tumor disease\n3. Patients with active brain metastases (patients with brain metastases or residue after resection with stable size for 6 months in MRI not older than 8 weeks, after consultation with the sponsor, are not excluded from the trial)\n4. Use of chemotherapy and radiotherapy within 2 weeks prior to start of trial medication\n5. Use of checkpoint inhibitors (having a marketing authorization) within a washout of 5 x t1/2 (half-life); patients with experimental checkpoint inhibitors at all\n6. Other investigational drug within the past 4 weeks before start of trial medication\n7. Patients undergoing renal dialysis\n8. Pulmonary disease with clinical relevant hypoxia\n9. Evidence of active, non-infectious pneumonitis or history of interstitial lung disease\n10. Cardiac disease: i.e. heart failure NYHA (New York Heart Association) III or IV, unstable coronary artery disease\n11. Active central nervous disease (e.g. Parkinson, multiple sclerosis, seizures) and stroke within last 6 months\n12. Active gastrointestinal ulceration or bleeding within the last 6 months unless related to underlying malignant disease\n13. Renal outflow obstruction, macroscopic or significant microscopic hematuria\n14. Active infectious diseases considered by investigator to be incompatible with protocol\n15. Major surgery within 28 days\n16. Autoimmune diseases requiring steroids at a dose above 10 mg prednisolone equivalent or other immunosuppressants\n17. Pregnant or breastfeeding women\n18. Psychiatric disorders, drug and/or alcohol abuse\n19. Known history of human immunodeficiency virus (HIV) or active/chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)\n20. Known hypersensitivity to GEM3PSCA excipients\n21. Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)\n22. Incapability of understanding purpose and possible consequences of the trial\n23. Patients who should not be included according to the opinion of the investigator",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Male or female patients, ≥ 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Male or female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Progressive PSCA positive cancer (urogenital tract (renal, transitional cell, prostate), non-small cell lung) refractory to standard treatments and with no other available standard or curative treatment",
            "criterions": [
                {
                    "exact_snippets": "Progressive PSCA positive cancer",
                    "criterion": "PSCA positive cancer",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "urogenital tract (renal, transitional cell, prostate), non-small cell lung",
                    "criterion": "cancer location",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "urogenital tract",
                                "renal",
                                "transitional cell",
                                "prostate",
                                "non-small cell lung"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to standard treatments",
                    "criterion": "treatment refractory",
                    "requirements": [
                        {
                            "requirement_type": "refractory",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no other available standard or curative treatment",
                    "criterion": "availability of standard or curative treatment",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Life expectancy of at least 2 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 2 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Platelets > 50,000/µl",
            "criterions": [
                {
                    "exact_snippets": "Platelets > 50,000/µl",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 50000,
                                "unit": "/µl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Hemoglobin > 9 g/dl",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin > 9 g/dl",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Adequate renal and hepatic laboratory assessments",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal ... laboratory assessments",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic laboratory assessments",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Adequate pulmonary function with oxygen saturation (SpO2) ≥ 90 % and no structural pulmonary disease which might jeopardize patient safety according to judgement of the investigator",
            "criterions": [
                {
                    "exact_snippets": "Adequate pulmonary function",
                    "criterion": "pulmonary function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "oxygen saturation (SpO2) ≥ 90 %",
                    "criterion": "oxygen saturation (SpO2)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no structural pulmonary disease",
                    "criterion": "structural pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Left ventricular ejection fraction (LVEF) of ≥ 45 %",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction (LVEF) of ≥ 45 %",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Existing port-system or central venous catheter resp. acceptance of implantation of a device",
            "criterions": [
                {
                    "exact_snippets": "Existing port-system or central venous catheter",
                    "criterion": "port-system or central venous catheter",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acceptance of implantation of a device",
                    "criterion": "implantation of a device",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. A female of childbearing potential may be enrolled providing she has a negative pregnancy test at screening visit and is routinely using a highly effective method of birth control resulting in a low failure rate (e.g. hormonal contraception, intrauterine device, total sexual abstinence or sterilization) until 3 months from the last study drug administration. Male patients must also practice a highly effective method of birth Control",
            "criterions": [
                {
                    "exact_snippets": "female of childbearing potential",
                    "criterion": "gender and reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive potential",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative pregnancy test at screening visit",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "routinely using a highly effective method of birth control",
                    "criterion": "birth control method",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "highly effective"
                        }
                    ]
                },
                {
                    "exact_snippets": "Male patients must also practice a highly effective method of birth Control",
                    "criterion": "male birth control method",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "highly effective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Able to give written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Able to give written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Other malignancy requiring active therapy",
            "criterions": [
                {
                    "exact_snippets": "Other malignancy requiring active therapy",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "requiring active therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Non-measurable tumor disease",
            "criterions": [
                {
                    "exact_snippets": "Non-measurable tumor disease",
                    "criterion": "tumor disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with active brain metastases (patients with brain metastases or residue after resection with stable size for 6 months in MRI not older than 8 weeks, after consultation with the sponsor, are not excluded from the trial)",
            "criterions": [
                {
                    "exact_snippets": "Patients with active brain metastases",
                    "criterion": "active brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with brain metastases or residue after resection with stable size for 6 months in MRI not older than 8 weeks",
                    "criterion": "brain metastases or residue after resection",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": {
                                "operator": "=",
                                "value": 6,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "MRI age",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Use of chemotherapy and radiotherapy within 2 weeks prior to start of trial medication",
            "criterions": [
                {
                    "exact_snippets": "Use of chemotherapy ... within 2 weeks prior to start of trial medication",
                    "criterion": "chemotherapy use",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Use of ... radiotherapy within 2 weeks prior to start of trial medication",
                    "criterion": "radiotherapy use",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Use of checkpoint inhibitors (having a marketing authorization) within a washout of 5 x t1/2 (half-life); patients with experimental checkpoint inhibitors at all",
            "criterions": [
                {
                    "exact_snippets": "Use of checkpoint inhibitors (having a marketing authorization) within a washout of 5 x t1/2 (half-life)",
                    "criterion": "use of checkpoint inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "authorization",
                            "expected_value": "having a marketing authorization"
                        },
                        {
                            "requirement_type": "washout period",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "x t1/2 (half-life)"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with experimental checkpoint inhibitors at all",
                    "criterion": "use of experimental checkpoint inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Other investigational drug within the past 4 weeks before start of trial medication",
            "criterions": [
                {
                    "exact_snippets": "Other investigational drug within the past 4 weeks before start of trial medication",
                    "criterion": "use of other investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 4 weeks before start of trial medication"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients undergoing renal dialysis",
            "criterions": [
                {
                    "exact_snippets": "Patients undergoing renal dialysis",
                    "criterion": "renal dialysis",
                    "requirements": [
                        {
                            "requirement_type": "undergoing",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Pulmonary disease with clinical relevant hypoxia",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary disease",
                    "criterion": "pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical relevant hypoxia",
                    "criterion": "hypoxia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically relevant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Evidence of active, non-infectious pneumonitis or history of interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "Evidence of active, non-infectious pneumonitis",
                    "criterion": "active, non-infectious pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Cardiac disease: i.e. heart failure NYHA (New York Heart Association) III or IV, unstable coronary artery disease",
            "criterions": [
                {
                    "exact_snippets": "Cardiac disease: i.e. heart failure NYHA (New York Heart Association) III or IV",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "NYHA III",
                                "NYHA IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiac disease: ... unstable coronary artery disease",
                    "criterion": "coronary artery disease",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Active central nervous disease (e.g. Parkinson, multiple sclerosis, seizures) and stroke within last 6 months",
            "criterions": [
                {
                    "exact_snippets": "Active central nervous disease (e.g. Parkinson, multiple sclerosis, seizures)",
                    "criterion": "central nervous disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke within last 6 months",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Active gastrointestinal ulceration or bleeding within the last 6 months unless related to underlying malignant disease",
            "criterions": [
                {
                    "exact_snippets": "Active gastrointestinal ulceration",
                    "criterion": "gastrointestinal ulceration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bleeding within the last 6 months",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Renal outflow obstruction, macroscopic or significant microscopic hematuria",
            "criterions": [
                {
                    "exact_snippets": "Renal outflow obstruction",
                    "criterion": "renal outflow obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "macroscopic ... hematuria",
                    "criterion": "macroscopic hematuria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "significant microscopic hematuria",
                    "criterion": "significant microscopic hematuria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Active infectious diseases considered by investigator to be incompatible with protocol",
            "criterions": [
                {
                    "exact_snippets": "Active infectious diseases considered by investigator to be incompatible with protocol",
                    "criterion": "active infectious diseases",
                    "requirements": [
                        {
                            "requirement_type": "compatibility with protocol",
                            "expected_value": "incompatible"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Major surgery within 28 days",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 28 days",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Autoimmune diseases requiring steroids at a dose above 10 mg prednisolone equivalent or other immunosuppressants",
            "criterions": [
                {
                    "exact_snippets": "Autoimmune diseases requiring steroids",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "steroids"
                        }
                    ]
                },
                {
                    "exact_snippets": "steroids at a dose above 10 mg prednisolone equivalent",
                    "criterion": "steroid dose",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg prednisolone equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Autoimmune diseases requiring ... other immunosuppressants",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "other immunosuppressants"
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Pregnant or breastfeeding women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding women",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Psychiatric disorders, drug and/or alcohol abuse",
            "criterions": [
                {
                    "exact_snippets": "Psychiatric disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "drug and/or alcohol abuse",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "drug and/or alcohol abuse",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Known history of human immunodeficiency virus (HIV) or active/chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)",
            "criterions": [
                {
                    "exact_snippets": "Known history of human immunodeficiency virus (HIV)",
                    "criterion": "human immunodeficiency virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active/chronic infection with hepatitis C virus (HCV)",
                    "criterion": "hepatitis C virus (HCV) infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active/chronic"
                        }
                    ]
                },
                {
                    "exact_snippets": "active/chronic infection with ... hepatitis B virus (HBV)",
                    "criterion": "hepatitis B virus (HBV) infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active/chronic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Known hypersensitivity to GEM3PSCA excipients",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to GEM3PSCA excipients",
                    "criterion": "hypersensitivity to GEM3PSCA excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)",
            "criterions": [
                {
                    "exact_snippets": "Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)",
                    "criterion": "likelihood to follow study protocol",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": "not likely"
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. Incapability of understanding purpose and possible consequences of the trial",
            "criterions": [
                {
                    "exact_snippets": "Incapability of understanding purpose and possible consequences of the trial",
                    "criterion": "understanding of trial purpose and consequences",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "23. Patients who should not be included according to the opinion of the investigator",
            "criterions": [
                {
                    "exact_snippets": "Patients who should not be included according to the opinion of the investigator",
                    "criterion": "investigator's opinion",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}