{
    "info": {
        "nct_id": "NCT04838548",
        "official_title": "An Open-Label, Multi-Cohort, Multi-center, Non-Randomized, Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer",
        "inclusion_criteria": "* Willing to sign the ICF and follow the requirements specified in the protocol.\n* Age: ≥18 years，both genders.\n* Expected survival time≥6 months.\n* Patients with histologically confirmed advanced non-small cell lung cancer, and without histologically confirmed small cell lung cancer (SCLC).\n* Positive EGFR expression in tumor specimen.\n* Failed in the prior second-line or above standard of care therapies.\n* Archival or biopsy tumor specimens should be provided.\n* Patients must have measurable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).\n* ECOG performance score 0 or 1.\n* AEs related to prior systemic chemotherapy and radical/extensive radiotherapy have recovered to ≤ Grade 1 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE V5.0).\n* No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.\n* Organ functions and coagulation function must meet the basic requirements.\n* Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* History of hypersensitivity to any component of the investigational product.\n* No documented progression after prior treatment, or recurrence during or after prior treatment.\n* Received radiotherapy, chemotherapy, biologicals, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment.\n* Presence of central nervous system metastasis.\n* Patients with significant clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage prior to the first dose of study drug.\n* Any severe or uncontrolled systemic disease judged by the investigator.\n* Patients with poorly controlled heart diseases.\n* Evidence of active infections, including Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection.\n* Active bacterial, viral, fungal, rickettsial, or parasitic infection requiring systemic therapy.\n* Prior history of other primary malignancies.\n* History of the following ophthalmologic abnormalities: severve dry eye syndrome; keratoconjunctivitis sicca; severe exposure keratitis; any other condition that may increase the risk of corneal epithelial damage.\n* History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy.\n* History of interstitial lung disease (ILD) or pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.\n* Pulmonary radiotherapy > 30 Gy within 6 months prior to first dose of study drug.\n* Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.\n* Patients with active autoimmune disease or history of autoimmune disease, who are using immunosuppressive agents or systemic hormone therapy and still receiving within 2 weeks prior to enrollment.\n* History of allogeneic tissue or solid organ transplant.\n* Female patients with a positive serum pregnancy test or who are breast feeding or do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.\n* Active uncontrolled concomitant diseases that might limit patient's compliance with study requirements, or compromise patient's ability to provide written informed consent.\n* Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Willing to sign the ICF and follow the requirements specified in the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Willing to sign the ICF",
                    "criterion": "informed consent form (ICF)",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "follow the requirements specified in the protocol",
                    "criterion": "protocol adherence",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age: ≥18 years，both genders.",
            "criterions": [
                {
                    "exact_snippets": "Age: ≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "both genders",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed genders",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expected survival time≥6 months.",
            "criterions": [
                {
                    "exact_snippets": "Expected survival time≥6 months.",
                    "criterion": "expected survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with histologically confirmed advanced non-small cell lung cancer, and without histologically confirmed small cell lung cancer (SCLC).",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed advanced non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "without histologically confirmed small cell lung cancer (SCLC)",
                    "criterion": "small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "not histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive EGFR expression in tumor specimen.",
            "criterions": [
                {
                    "exact_snippets": "Positive EGFR expression in tumor specimen.",
                    "criterion": "EGFR expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Failed in the prior second-line or above standard of care therapies.",
            "criterions": [
                {
                    "exact_snippets": "Failed in the prior second-line or above standard of care therapies.",
                    "criterion": "prior standard of care therapies",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        },
                        {
                            "requirement_type": "line of therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "line"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Archival or biopsy tumor specimens should be provided.",
            "criterions": [
                {
                    "exact_snippets": "Archival or biopsy tumor specimens should be provided.",
                    "criterion": "tumor specimens",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have measurable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).",
            "criterions": [
                {
                    "exact_snippets": "measurable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1)",
                    "criterion": "lesions",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "according to RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance score 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance score 0 or 1",
                    "criterion": "ECOG performance score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AEs related to prior systemic chemotherapy and radical/extensive radiotherapy have recovered to ≤ Grade 1 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE V5.0).",
            "criterions": [
                {
                    "exact_snippets": "AEs related to prior systemic chemotherapy ... have recovered to ≤ Grade 1 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE V5.0).",
                    "criterion": "AEs related to prior systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AEs related to ... radical/extensive radiotherapy have recovered to ≤ Grade 1 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE V5.0).",
                    "criterion": "AEs related to radical/extensive radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.",
            "criterions": [
                {
                    "exact_snippets": "No severe cardiac dysfunction",
                    "criterion": "cardiac dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "left ventricular ejection fraction (LVEF) ≥ 50%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Organ functions and coagulation function must meet the basic requirements.",
            "criterions": [
                {
                    "exact_snippets": "Organ functions ... must meet the basic requirements.",
                    "criterion": "organ functions",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "must meet the basic requirements"
                        }
                    ]
                },
                {
                    "exact_snippets": "coagulation function must meet the basic requirements.",
                    "criterion": "coagulation function",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "must meet the basic requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Patients with childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception during the treatment and for 6 months after the last dose of treatment",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the treatment and for 6 months after the last dose of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* History of hypersensitivity to any component of the investigational product.",
            "criterions": [
                {
                    "exact_snippets": "History of hypersensitivity to any component of the investigational product.",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No documented progression after prior treatment, or recurrence during or after prior treatment.",
            "criterions": [
                {
                    "exact_snippets": "No documented progression after prior treatment",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrence during or after prior treatment",
                    "criterion": "disease recurrence",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "during prior treatment",
                                "after prior treatment"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received radiotherapy, chemotherapy, biologicals, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Received radiotherapy ... within 4 weeks prior to the first dose of study treatment.",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... chemotherapy ... within 4 weeks prior to the first dose of study treatment.",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... biologicals ... within 4 weeks prior to the first dose of study treatment.",
                    "criterion": "biologicals",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... immunotherapy ... within 4 weeks prior to the first dose of study treatment.",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... other anti-tumor drugs within 4 weeks prior to the first dose of study treatment.",
                    "criterion": "other anti-tumor drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of central nervous system metastasis.",
            "criterions": [
                {
                    "exact_snippets": "Presence of central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with significant clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage prior to the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "pleural, abdominal or pericardial effusion",
                    "criterion": "effusion",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "pleural",
                                "abdominal",
                                "pericardial"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring puncture drainage",
                    "criterion": "effusion",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "puncture drainage"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any severe or uncontrolled systemic disease judged by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "severe or uncontrolled systemic disease",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with poorly controlled heart diseases.",
            "criterions": [
                {
                    "exact_snippets": "poorly controlled heart diseases",
                    "criterion": "heart diseases",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of active infections, including Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection.",
            "criterions": [
                {
                    "exact_snippets": "active infections",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatitis B",
                    "criterion": "Hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatitis C",
                    "criterion": "Hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "human immunodeficiency virus (HIV) infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active bacterial, viral, fungal, rickettsial, or parasitic infection requiring systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "Active bacterial ... infection requiring systemic therapy.",
                    "criterion": "bacterial infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active ... viral ... infection requiring systemic therapy.",
                    "criterion": "viral infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active ... fungal ... infection requiring systemic therapy.",
                    "criterion": "fungal infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active ... rickettsial ... infection requiring systemic therapy.",
                    "criterion": "rickettsial infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active ... parasitic infection requiring systemic therapy.",
                    "criterion": "parasitic infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior history of other primary malignancies.",
            "criterions": [
                {
                    "exact_snippets": "Prior history of other primary malignancies",
                    "criterion": "other primary malignancies",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of the following ophthalmologic abnormalities: severve dry eye syndrome; keratoconjunctivitis sicca; severe exposure keratitis; any other condition that may increase the risk of corneal epithelial damage.",
            "criterions": [
                {
                    "exact_snippets": "History of the following ophthalmologic abnormalities: severve dry eye syndrome",
                    "criterion": "severe dry eye syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of the following ophthalmologic abnormalities: ... keratoconjunctivitis sicca",
                    "criterion": "keratoconjunctivitis sicca",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of the following ophthalmologic abnormalities: ... severe exposure keratitis",
                    "criterion": "severe exposure keratitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of the following ophthalmologic abnormalities: ... any other condition that may increase the risk of corneal epithelial damage",
                    "criterion": "condition that may increase the risk of corneal epithelial damage",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy.",
            "criterions": [
                {
                    "exact_snippets": "History of severe skin disease requiring interruption of previous EGFR targeted therapy",
                    "criterion": "severe skin disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "treatment_interruption",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic skin disease requiring oral or intravenous therapy",
                    "criterion": "chronic skin disease",
                    "requirements": [
                        {
                            "requirement_type": "chronicity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "oral",
                                "intravenous"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of interstitial lung disease (ILD) or pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.",
            "criterions": [
                {
                    "exact_snippets": "History of interstitial lung disease (ILD)",
                    "criterion": "interstitial lung disease (ILD)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe chronic obstructive pulmonary disease",
                    "criterion": "chronic obstructive pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe pulmonary insufficiency",
                    "criterion": "pulmonary insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic bronchospasm",
                    "criterion": "bronchospasm",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pulmonary radiotherapy > 30 Gy within 6 months prior to first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary radiotherapy > 30 Gy within 6 months prior to first dose of study drug.",
                    "criterion": "pulmonary radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "Gy"
                            }
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 6 months prior to first dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary embolism ... within 3 months prior to the first dose of study drug.",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "deep vein thrombosis within 3 months prior to the first dose of study drug.",
                    "criterion": "deep vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with active autoimmune disease or history of autoimmune disease, who are using immunosuppressive agents or systemic hormone therapy and still receiving within 2 weeks prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Patients with active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of autoimmune disease",
                    "criterion": "history of autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "using immunosuppressive agents",
                    "criterion": "use of immunosuppressive agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic hormone therapy",
                    "criterion": "use of systemic hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "still receiving within 2 weeks prior to enrollment",
                    "criterion": "time since last use of immunosuppressive agents or systemic hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allogeneic tissue or solid organ transplant.",
            "criterions": [
                {
                    "exact_snippets": "History of allogeneic tissue or solid organ transplant.",
                    "criterion": "allogeneic tissue transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of allogeneic tissue or solid organ transplant.",
                    "criterion": "solid organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female patients with a positive serum pregnancy test or who are breast feeding or do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "positive serum pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "breastfeeding"
                        }
                    ]
                },
                {
                    "exact_snippets": "do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment",
                    "criterion": "contraceptive agreement",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "do not agree"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active uncontrolled concomitant diseases that might limit patient's compliance with study requirements, or compromise patient's ability to provide written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Active uncontrolled concomitant diseases",
                    "criterion": "concomitant diseases",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "limit patient's compliance with study requirements",
                    "criterion": "compliance with study requirements",
                    "requirements": [
                        {
                            "requirement_type": "limitation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "compromise patient's ability to provide written informed consent",
                    "criterion": "ability to provide written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "compromise",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Other conditions inappropriate for participation ... at the discretion of the investigator.",
                    "criterion": "other conditions",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness for participation",
                            "expected_value": "at the discretion of the investigator"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}